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Triazolam Trial In Healthy Subjects To Compare Bioavailability Between Formulations Of Triazolam To Determine Their Bioequivalence In Terms Of Rate And Magnitude Of Absorption

2014-08-27 03:17:49 | BioPortfolio

Summary

The purpose of this study is to compare the bioavailability of two oral formulations of Triazolam in healthy volunteers, in order to determine that they are bioequivalent.

Description

The bioequivalence trial of triazolam is due to change in manufacture site.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Healthy Volunteers

Intervention

Triazolam, Triazolam

Status

Not yet recruiting

Source

Pfizer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:49-0400

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Medical and Biotech [MESH] Definitions

A short-acting benzodiazepine used in the treatment of insomnia. Some countries temporarily withdrew triazolam from the market because of concerns about adverse reactions, mostly psychological, associated with higher dose ranges. Its use at lower doses with appropriate care and labeling has been reaffirmed by the FDA and most other countries.

Persons with no known significant health problems who are recruited to participate in research to test a new drug, device, or intervention as controls for a patient group. (from http://clinicalcenter.nih.gov/recruit/volunteers.html, accessed 2/14/2013)

Hospital or other institutional ethics committees established to consider the ethical dimensions of patient care. Distinguish from ETHICS COMMITTEES, RESEARCH, which are established to monitor the welfare of patients or healthy volunteers participating in research studies.

Human experimentation that is not intended to benefit the subjects on whom it is performed. Phase I drug studies (CLINICAL TRIALS, PHASE I AS TOPIC) and research involving healthy volunteers are examples of nontherapeutic human experimentation.

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