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  • healthy volunteers  (18)
  • Springer  (18)
  • American Chemical Society
  • Elsevier
  • 2000-2004
  • 1985-1989  (18)
  • 1987  (18)
Collection
Keywords
Publisher
  • Springer  (18)
  • American Chemical Society
  • Elsevier
Years
  • 2000-2004
  • 1985-1989  (18)
Year
  • 1
    Electronic Resource
    Electronic Resource
    Effect of concomitant food intake on absorption kinetics of fenoldopam (SK&F 82526) in healthy volunteers (1987)
    Springer
    European journal of clinical pharmacology 32 (1987), S. 103-106 
    Details
    ISSN: 1432-1041
    Keywords: fenoldopam ; peripheral dopamine agonist ; pharmacokinetics ; absorption ; food effects ; healthy volunteers
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Eight healthy volunteers participated in an open crossover study to assess the effect of a standardised meal on the systemic availability of a single oral dose of fenoldopam mesylate 100 mg. Subjects were studied on four separate occasions, twice fasting and twice fed in randomised, balanced order. Plasma and urine samples were obtained before and at regular intervals up to 25 h post dose. Measurement of fenoldopam (SK&F 82526) and its 8-sulphate metabolite (SK&F 87782) were by means of HPLC-EC analysis. Area under the plasma concentration time curve (AUC) and maximum detected plasma concentration (Cmax) for fenoldopam and SK&F 87782 were significantly reduced whereas time to maximum concentration was significantly increased with food. Using AUC's for fenoldopam and SK&F 87782, mean relative bioavailabilities were 35% and 81% respectively under fed compared with fasting conditions. Twenty-four hour excretion of fenoldopam was significantly reduced with food, but excretion of SK&F 87782 was apparently unchanged. Mean relative bioavailabilities calculated from these data were 83% and 86% respectively. Relatively large inter-subject variability in AUC and Cmax were seen, but intra-subject variability was not marked. Mild symptoms associated with vasodilation were reported on all study days.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00609968
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  • 2
    Electronic Resource
    Electronic Resource
    Hypotensive effects of ovine and human corticotrophin-releasing factors in man (1987)
    Springer
    European journal of clinical pharmacology 31 (1987), S. 531-534 
    Details
    ISSN: 1432-1041
    Keywords: corticotrophin-releasing factor ; hypotension ; ovine CRF ; human CRF ; healthy volunteers ; tachycardia ; plasma noradrenaline
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The haemodynamic effects of i.v. bolus injections of 100 and 200 µg ovine CRF and human CRF in man have been compared. Neither ovine CRF 100 µg nor human CRF 100 µg caused a significant change in blood pressure, although the pulse rate was increased in all the subjects tested. The mean maximum increase in pulse rate after human CRF was almost twice that after ovine CRF (21 vs 12 beats·min−1;p〈0.05). After 200 µg ovine CRF in all subjects the diastolic blood pressure declined gradually from 77 mm Hg to a nadir of 67 mm Hg at 22 min (p〈0.002). After 200 µg human CRF diastolic blood pressure fell from 78 mm Hg to a nadir of 61 mm Hg at 6 min (p〈0.002); the fall after human CRF was significantly greater than after ovine CRF (p〈0.05). After 200 µg ovine CRF there was a slight increase in pulse rate lasting for 6 min, and after 200 µg human CRF there was a marked (reflex) tachycardia for 30 min. Only after the highest dose of human CRF did a slight increase in systolic blood pressure occur. The haemodynamic effects of both doses of human CRF were accompanied by significant increases in plasma noradrenaline concentrations, which were significantly greater after the higher dose.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00606625
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  • 3
    Electronic Resource
    Electronic Resource
    Effect of 40749 RP on basal and sham feeding stimulated gastric secretion in man (1987)
    Springer
    European journal of clinical pharmacology 33 (1987), S. 479-482 
    Details
    ISSN: 1432-1041
    Keywords: 40749 RP ; gastric acid secretion ; gastric antisecretory agent ; sham feeding ; healthy volunteers ; vagal stimulation
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary 40749 RP, a pyridyl-2-tetrahydrothiophene derivative, is known to be a potent inhibitor of the gastric acid response to pentagastrin, betazole and a meal. In 6 healthy young volunteers, a single oral dose of 2 mg · kg−1 greatly reduced the gastric acid secretory response to sham-feeding. By contrast, neither gastric pepsin nor the plasma PP response were altered by the drug. No change was observed in plasma gastrin, motilin, VIP or somatostatin concentrations. The results show that 40749 RP is also active on the pure vagus-stimulated gastric acid secretion. The lack of effect upon gastric pepsin and plasma PP suggests that 40749 RP is not likely to act on the basolateral cholinergic receptor and that it affects further cellular steps involved in hydrogen ion secretion.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00544239
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  • 4
    Electronic Resource
    Electronic Resource
    Uncorrected pre-ejection period: A simple non-invasive measurement for pharmacodynamic screening of inotropic activity (1987)
    Springer
    European journal of clinical pharmacology 31 (1987), S. 559-562 
    Details
    ISSN: 1432-1041
    Keywords: systole ; inotropic activity ; pharmacodynamic screening ; mexelitine ; disopyramide ; healthy volunteers ; pre-ejection period
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Since heart rate (HR) is an important determinant of the duration of systole, systolic time intervals (STI) from 8 healthy subjects were examined after infusion of atropine. As no overall correlation was found between HR and pre-ejection period (PEP), the results confirm the need for individual estimates of the correction of the left ventricular ejection time (LVET) and the total electromechanical systole (OS2). In the same subjects the sensitivity of PEP to minor negative inotropic effects of mexiletine and disopyramide measured at Cmax was confirmed. Thus, in addition to its simplicity and reliability, the sensitivity of the uncorrected PEP should encourage use of this technique as part of any screening system for the early detection of an inotropic effect of new chemical entities.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00606630
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  • 5
    Electronic Resource
    Electronic Resource
    A comparison of oral midazolam, nitrazepam and placebo in young and elderly subjects (1987)
    Springer
    European journal of clinical pharmacology 32 (1987), S. 253-257 
    Details
    ISSN: 1432-1041
    Keywords: midazolam ; nitrazepam ; young ; elderly ; pharmacodynamics ; healthy volunteers
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Twelve young and twelve elderly subjects received a single dose orally of midazolam 15 mg, nitrazepam 5 mg and placebo in a double-blind, crossover comparison. Midazolam acted rapidly, producing a deep sleep at 1 h in fifteen subjects compared to two after Nitrazepam and none after placebo. No comparison of psychomotor tests was possible at this time, but such tests showed that there was no detectable subjective or objective psychomotor impairment at 4 h postdose with either drug. However, the EEG scores strongly suggested that volunteers were more sleepy at 8 h after nitrazepam in comparison to placebo or midazolam. Both groups appeared to handle the drug in a similar manner, there being no significant differences between the groups in the plasma concentration time curves of nitrazepam, or midazolam. The elderly had higher concentrations of α-hydroxymidazolam. This accounted for a small proportion of the total plasma benzodiazepine concentration, and the mean area under the curve for midazolam and metabolite was not significantly different in the old from that in the young.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00607572
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  • 6
    Electronic Resource
    Electronic Resource
    Enhancement of the ACTH response to human CRH by pretreatment with the antiglucocorticoid RU-486 (1987)
    Springer
    European journal of clinical pharmacology 31 (1987), S. 609-611 
    Details
    ISSN: 1432-1041
    Keywords: ACTH response ; antiglucocorticoid RU-486 ; plasma cortisol level ; corticotrophin releasing hormone CRH ; healthy volunteers
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The response of ACTH to an i.v. bolus injection of 100 µg human CRH at 09.00 h was investigated in five healthy men with and without pretreatment with the antiglucocorticoid RU-486 100 mg given orally 7 h before the injection of CRH. In all five subjects the plasma cortisol level immediately before CRH administration at 09.00 h was significantly higher after pretreatment with the antiglucocorticoid (17.1 vs 11.1 µg/100 ml). Despite this higher baseline cortisol level, in all subjects the maximal CRH-induced ACTH increase was more pronounced after RU-486 loading (Δmax ACTH 39 vs 26 pg/ml). This observation proves that in man physiological concentrations of cortisol determine the response of the pituitary to CRH. Furthermore, the findings suggest reduced circulating glucocorticoid activity after administration of 100 mg RU-486, not completely compensated by an increase in plasma cortisol.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00606640
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  • 7
    Electronic Resource
    Electronic Resource
    Pharmacokinetics and absolute bioavailability of salbutamol in healthy adult volunteers (1987)
    Springer
    European journal of clinical pharmacology 32 (1987), S. 631-634 
    Details
    ISSN: 1432-1041
    Keywords: salbutamol ; albuterol ; pharmacokinetics ; bioavailability ; healthy volunteers
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Salbutamol was administered to sixteen healthy male volunteers intravenously and by mouth in liquid, tablet, and capsule form using a Latin-Squares design. Pharmacokinetic parameters from intravenous data were similar to previously reported values obtained with oral administration, with a mean terminal half-life of 3.8 h and a mean clearance of 439 ml·min−1·1.73 m−2. Peak plasma concentrations of 10–20 ng·ml−1 were obtained 1–3 h following oral administration. The absolute bioavailability of each of the oral preparations was 44%. While statistically significant differences in lag time and time to peak concentration were noted among the various oral preparations, the drug is rapidly absorbed in all three dosage forms and the observed differences are unlikely to be of clinical significance.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF02456001
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  • 8
    Electronic Resource
    Electronic Resource
    Absorption of an aqueous solution of a new synthetic somatostatin analogue administered to man by gavage (1987)
    Springer
    European journal of clinical pharmacology 33 (1987), S. 167-171 
    Details
    ISSN: 1432-1041
    Keywords: somatostatin analogue ; oral formulation ; gastrointestinal absorption ; SMS 201-995 ; healthy volunteers
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary To determine the local gastrointestinal absorption of a new synthetic somatostatin analogue (SMS 201-995 = Sandostatin), an intestinal tube was passed in eight healthy volunteers and on different days an aqueous solution was administered at four different locations: stomach, proximal duodenum, ligament of Treitz and jejunum. In a follow-up study, an oro-ileal tube was passed in six of the original volunteers and the drug solution was administered in to the terminal ileum. The aqueous solution of SMS was rapidly absorbed from the gastrointestinal tract after local application, and it was well tolerated. Absorption of the drug from the different sites was comparable, although there was a tendency to decreased peptide absorption after ileal administration. Absorption of the drug was quite variable between the subjects and the different locations. The dose-corrected systemic availability relative to subcutaneous administration in another study was 0.28%. However, significant plasma SMS concentrations were achieved, suggesting that oral delivery of the polypeptide may eventually be possible for long-term treatment of a variety of disorders.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00544562
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  • 9
    Electronic Resource
    Electronic Resource
    Enoxacin — a potent inhibitor of theophylline metabolism (1987)
    Springer
    European journal of clinical pharmacology 33 (1987), S. 227-230 
    Details
    ISSN: 1432-1041
    Keywords: enoxacin ; theophylline ; drug interaction ; healthy volunteers ; adverse effects ; pharmacokinetics ; renal tubular excretion
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The mechanism of the theophylline-enoxacin interaction has been studied in six healthy subjects. Theophylline 250 mg was administered p.o., twice daily for 11 days in a sustained release dosage form. On the 4th day of treatment, blood samples were taken every 2 h and urine was collected over 1 dose interval. From Days 5 to 11 coated tablets of enoxacin 400 mg b.i.d. were coadministered. On Day 11 blood and urine were collected as on Day 4. The mean plasma theophylline concentration rose from 4.4 to 15.1 mg/l, corresponding to a 73.6% reduction in total clearance. The urinary excretion of unchanged theophylline increased from 12.7 to 35.3%, whereas the production of metabolites was reduced (1-demethylation 81.4%; 3-demethylation 83.1%, 8-hydroxylation 74.6%). The results indicate that the theophylline-enoxacin interaction may be due to inhibition of the cytochrome P-450 isozymes responsible for theophylline metabolism. Unexpectedly, the renal clearance of theophylline metabolites was found to be drastically reduced when enoxacin was coadministered. This led to unchanged or even to elevated plasma levels of the metabolites. The mechanism of this interaction is still to be elucidated, but it may be due to competition for renal tubular secretion.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00637553
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  • 10
    Electronic Resource
    Electronic Resource
    Influence of smoking and gender on the disposition kinetics of metoprolol (1987)
    Springer
    European journal of clinical pharmacology 33 (1987), S. 355-361 
    Details
    ISSN: 1432-1041
    Keywords: metoprolol ; smoking ; gender ; pharmacokinetics ; HPLC ; healthy volunteers
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The purpose of this study was to examine the influence of cigarette smoking and gender on the pharmacokinetics of metoprolol. Eighteen volunteers with no evidence of clinical disease each randomly received the following doses of metoprolol tartrate: 100 mg orally, 200 mg orally and 20 mg as a constant-rate intravenous infusion over 20 min. The only significant difference between smokers (S) and nonsmokers (NS) was that S had a larger steady-state volume of distribution (3.3 vs 2.5 l/kg). There were no differences in half-life, systemic clearance or bioavailability (f). No differences were observed between males (M) and females (FM) for any of the kinetic parameters examined. Systemic bioavailability varied markedly between subjects (range: 15 to 92%). In fifteen of the eighteen subjects, f was higher after the 200-mg dose compared to the 100-mg dose. These results suggest that metoprolol may be subject to saturable presystemic elimination and extend the previous observations of Johnsson et al. [1] who showed that f increased from 31% to 46% when doses were increased from 20 to 100 mg. However, the difference in f as the dose is increased is unlikely to be clinically significant since the mean difference is smaller than the variation in f among subjects.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00637630
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