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Biomedical subjects

D Warot

Publications and source records attributed to D Warot.

At least 37 records · Page 2Linked to original sources
PubMed1989

Effects of dihydroergotamine on psychomotor function, neuroendocrine parameters and blood pressure, in healthy volunteers.

Following the infusion of 15 micrograms/kg of dihydroergotamine (DHE) a 50-fold rise in growth hormone plasma levels was observed in 9 healthy volunteers. Prolactin (PRL) secretion was depressed 240 minutes post infusion. For 170 min, diastolic blood pressure was increased reaching a peak of +19 mmHg at the end of the infusion. Mild sedation and nausea were induced by the treatment for a total duration of 60 min.

Adult↗
PubMed1988

Assessment of erectogenic properties of apomorphine and yohimbine in man.

1. In a four period, double-blind, placebo-controlled study, apomorphine (0.009 mg kg-1 subcutaneous route) and yohimbine (0.30 mg kg-1 i.v. route) were administered to 10 male healthy volunteers. Penile circumference was monitored using plethysmography and subjective sexual arousal was self-assessed. Data were collected before, during and after a stimulation session during which 50 erotic slides were projected to the subjects. 2. Apomorphine induced an erection starting from the fourth minute post-injection, and potentiated the visually-induced response. Self assessment showed increased tumescence and rigidity without modifications of sexual arousal. 3. Yohimbine did not modify penile diameter without stimulation and did not affect the physiological response to erotic stimuli. 'Sexual excitement' was decreased by yohimbine during the post-stimulation phase. One subject experienced severe anxiety while he was infused with yohimbine. 4. These results are discussed with reference to animal data and to recent studies carried out in impotent patients.

Adult↗
PubMed1987

Troleandomycin-triazolam interaction in healthy volunteers: pharmacokinetic and psychometric evaluation.

Seven healthy volunteers received a single oral dose of triazolam 0.25 mg after 7 days on troleandomycin 2 g/day p.o. or placebo in a double-blind cross-over study. Plasma triazolam and psychometric and memory tests (including Critical Flicker Fusion threshold, Choice Reaction Time, Digit Symbol Substitution and Self-Rating Scales) were assessed at regular intervals after the final treatment. Troleandomycin was found to prolong the psychomotor impairment and amnesia produced by triazolam. There was a significant enhancement of the AUC, the peak concentration and the delay to tmax of triazolam after 7 days treatment with troleandomycin compared to placebo. Thus, there is a pharmacokinetic interaction, and the combination of triazolam and troleandomycin should be avoided or the dose of triazolam should be adjusted. The most likely mechanism is a diminished hepatic first-pass effect, and a decrease in the apparent oral clearance of triazolam.

Adult↗
PubMed1987

Lack of sleep-inducing properties of propranolol (80 mg) in chronic insomniacs previously treated by common hypnotic medications.

In a double-blind, placebo-controlled crossover trial, propranolol 80 mg did not show any hypnotic properties and even increased the insomnia in a sample of 37 patients previously treated chronically with hypnotic medication (mostly benzodiazepines). This worsening of the insomnia is consistent with the observations of sleep disturbance at the beginning of treatment with beta-blocking drugs. This lack of efficacy suggests that the anti-stress or anxiolytic properties of propranolol do not apply to the rebound insomnia seen when stopping treatment with hypnotic drugs.

Adult↗
PubMed1987

Comparative effects of zopiclone, triazolam and placebo on memory and psychomotor performance in healthy volunteers.

This study evaluated the effects of acute doses of zopiclone (7.5 mg), triazolam (0.25 mg) and placebo on memory and psychomotor performance of 12 normal volunteers. The subjects received both drugs in a repeated measure, double-blind Latin square design. The tests (CFF, CRT, DSST, memory assessments) were performed before and 2 and 6 hr after treatment. Zopiclone and triazolam induced an anterograde amnesia affecting short-term and long-term memory which lasted less than 6 hr. No retrograde amnesia was observed. Two hr after drug intake of both hypnotics psychomotor performances were significantly altered compared with placebo. The subjects also felt more drowsy, dizzy, clumsy and tired, and less alert and energetic 2 hr after zopiclone and triazolam compared to placebo. There was no difference between the effects of the two hypnotics at the doses studied.

Adult↗
PubMed1983

Hypnotic activity of brotizolam: a study in general practice.

A double-blind, crossover study was carried out in general practice on the hypnotic activity of 0.25 mg brotizolam in patients aged between 18 and 70 years complaining of insomnia (11 men, 28 women). Patients reported that they slept better, that they awoke less frequently and that they slept longer with brotizolam than with placebo. Overall the patients preferred brotizolam to placebo, and subjective assessments of well-being after brotizolam did not differ from those after placebo. Brotizolam was well tolerated and there were no incidents of note.

Adolescent↗
PubMedDate not supplied

Beraprost sodium-fluindione combination in healthy subjects: pharmacokinetic and pharmacodynamic aspects.

Beraprost sodium (BPS), an orally active PGI2 (prostaglandine 12) analogue possesses vasodilatating and platelet aggregation inhibiting properties. It is being developed in peripheral arterial occlusive disease. As in future clinical practice BPS might be co-prescribed with oral anticoagulants, we investigated its interaction with fluindione, a vitamin K antagonist in healthy subjects in a randomised, double-blind, placebo-controlled, crossover study. Twelve healthy Caucasian male subjects randomly received BPS 40 microg t.i.d. or placebo for 3 days. There was a 7 day wash out between the two treatment periods. On day 3 of each treatment, the subjects ingested concomitantly a single oral dose of 20 mg of fluindione. The main assessment criterion was fluindione's pharmacokinetics. Secondarily, pharmacodynamic measurements of coagulation (prothrombin time, and International Normalised Ratio, INR) and platelet function (in vitro closure time assessed by PFA-100) were performed. Fluindione was assayed by HPLC with UV detection up to 96 h post-drug. No statistical difference could be evidenced on any fluindione pharmacokinetic parameters between BPS and placebo phases: t 1/2 (h): 35.9 (8.2) vs. 34.0 (4.2) [90% CI 105.8 (95.5-116.2)]; T(max) (h): 2.0 (0.5-6.0) vs. 4.0 (0.5-6.0) [90% CI 136.4 (70.7-208.9)]; Cmax (mg/L): 3.1 (0.6) vs. 2.9 (0.5) [90% CI 94.1 (85.8-103.2)]; AUC 0-inf (mg/h/L): 117.0 (31.5) vs. 113.9 (33.8) [90% CI 97.6 (87.5-108.8)]. The studied doses of BPS did not affect platelet function, at least as assessed by the in vitro platelet function testing. Twenty milligrams of fluindione marginally modified the PT ratio and INR, however, no statistically significant difference was found between BPS and placebo phases. In conclusion, a 3 day regimen of BPS 40 microg t.i.d. by oral route does not seem to affect pharmacokinetic parameters of a fluindione 20 mg single dose.

Administration, Oral↗
PubMedDate not supplied

[Comparative effects of ginkgo biloba extracts on psychomotor performances and memory in healthy subjects].

The effect on psychomotor and mnesic performances of acute oral dose (600 mg) of 2 Ginkgo biloba extracts were evaluated in twelve healthy female in a dummy placebo-controlled double blind study. Tests were performed comprising: objective measures of vigilance [critical flicker frequency (CFF), choice reaction time (CRT)], memory tasks (pictures and Sternberg scanning tests) and self-rating evaluation (visual analogue scales). Tests session took place before and 1 hour post-dosing. No statistically significant changes from placebo were observed on CFF, CRT or subjective rating of drug effects. No differences between treatment were evidenced on Sternberg scanning test and pictures recognition. Comparing to baseline, free recall score, while decreasing under placebo and Ginkgo, remained the same under Tanakan. As the differences between treatment are localized on one test, it appears important to examine the reproductility in healthy subjects. In order to verify the clinical relevance of these results, they need to be replicated in older healthy volunteers with age-associated memory impairment.

Adult↗
PubMedDate not supplied

[Drug evaluation in healthy volunteers. Legislative and ethical aspects].

Studies in healthy volunteers have been legalized since December 20th 1988 in France. The healthy volunteer is employed for a variety of studies in phases I and IV of drug development. This type of research can equally be called nontherapeutic in nature. Every experiment involving healthy volunteers should be approved by the Ethics Committee. Using volunteers within the department, company or other organisation, while offering advantages for the investigator should be prohibited as freedom of concept might not be safeguarded. As well, financial incentives may over-persuade individuals, including students, who have low incomes and promote the "professional volunteer". To avoid this problem, French law planned a national register. The potential benefits of such a disposition are still unknown. Having been given appropriate information concerning the drug trial, his obligations and rights, the healthy volunteer gives his written consent. Specific recommendations for nontherapeutic assessments of drug effects are given concerning prisoners, the mentally handicapped, women with a risk of frequency, children. Ethical considerations concerning research on a healthy population must go beyond the law recently promulgated in France.

Drug Evaluation↗
PubMedDate not supplied

[Personality of healthy volunteers. Normality and paradox].

The personality characteristics of 62 subjects to be screened for eligibility in psychopharmacology studies have been assessed. The psychological screening comprised the Cattell anxiety scale (CAS), the Eysenck Personality inventory (EPI) and the Minnesota Multiphasic Personality Inventory (MMPI) in its complete version (550 items). The comparison of the results to a population matched for age and status showed that the anxiety level was not different, extraversion factor was higher (p less than 0.001) and various personality traits were different. The most striking differences were observed on the factors: Psychopathic deviation, Mania, Schizophrenia greater than controls and social introversion lower than controls. These differences may evoke several biases, such as a recruitment bias or a specific personality pattern of young healthy subjects. In order to discuss these hypothesis, further comparisons with other centers are required to conclude.

Adult↗
PubMedDate not supplied

[Myasthenia gravis and drugs].

Several drugs are known to aggravate myasthenia gravis or to induce myasthenia like syndromes. Drugs which interfere with neuro-muscular transmission act either through a direct effect at the neuro-muscular junction or as with D. Penicillamine through an immunological action. For some drugs, the information available indicate their harmfulness in myasthenia gravis, so they are contraindicated. For others, the clinical effect is not so well established, nevertheless if necessary they can be used with caution.

Humans↗
PubMedDate not supplied

[Effects of 3 doses of maprotiline (25, 50 and 75 mg) on alertness and memory in healthy volunteers].

The effects on psychomotor and mnesic performance of acute oral doses of maprotiline (25, 50 and 75 mg) were evaluated in twelve healthy men in a placebo-controlled double blind study. A battery of tests was performed comprising: objective measures (critical flicker frequency, choice reaction time, memory tasks) and self rating evaluation (visual analogue scales). Tests session took place 15 hours after each treatment. Plasma concentrations of maprotiline were determined. Compared with placebo, maprotiline induced psychomotor impairment on both objective and subjective assessment in a dose related manner. No significant difference between maprotiline and placebo on memory test could be evidenced.

Adult↗