Healthy
Conditions
Keywords
Alprazolam, Tafil, Xanax, Bioequivalence, Drug Kinetics
Brief summary
The purpose of this study is to compare bioavailability between formulations of alprazolam in tablets to determine their bioequivalence in terms of rate and magnitude of absorption.
Interventions
DRUGAlprazolam
Single tablet
Sponsors
Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers (male or female) * Age between 18-40 years * body mass index (Quetelet´s index) between 18-27
Exclusion criteria
* Unhealthy subjects * Volunteers who require any medication over the course of the study * Volunteers who have received investigational drugs within 60 days prior to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establish Cmax, Tmax, elimination half life, area below the curve from zero to t, and area below the curve from zero to infinity (ABC 0-∞) of the two formulations of Alprazolam. | 10 days |
| Statistically compare the bioavailability of the pharmaceutical formulations of Alprazolam studied, to establish or rule out the existence of bioequivalence. | 10 days |
Secondary
| Measure | Time frame |
|---|---|
| Investigate the safety of both preparations based on the record of adverse events on completing both study periods. | 10 days |
Outcome results
None listed