A Study Of Two Oral Preparations Of 2 Mg Alprazolam In Healthy Volunteers Under Fasting Conditions
This study has been withdrawn prior to enrollment.
Sponsor:
Pfizer
Collaborator:
Centro de Investigacion Farmacologica y Biofarmaceutica SA de CV
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01046162
First received: January 7, 2010
Last updated: August 5, 2010
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Alprazolam |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | An Open Label, Crossover, Randomized Study of Two Periods, Two Treatments, Two Sequences, and a Single Dose of Two Oral Drug Products of Alprazolam 2mg (Tafil ® 2 mg, Product of Pharmacia & Upjohn SA de CV vs Xanax ® 2 mg, Product of Pfizer Pharmaceuticals LLC) in Healthy Volunteers in Fasting Conditions |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- Statistically compare the bioavailability of the pharmaceutical formulations of Alprazolam studied, to establish or rule out the existence of bioequivalence. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Investigate the safety of both preparations based on the record of adverse events on completing both study periods. [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 26 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Tafil Tablets 2 mg Pharmacia Upjohn |
Drug: Alprazolam
Single tablet
Other Name: Tafil Pharmacia Upjohn
|
| Active Comparator: Xanax Tablets 2 mg Pfizer LLC |
Drug: Alprazolam
Single tablet
Other Name: Xanax Pfizer
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01046162 History of Changes |
| Other Study ID Numbers: | A6131021 |
| Study First Received: | January 7, 2010 |
| Last Updated: | August 5, 2010 |
| Health Authority: | Mexico: Ministry of Health |
Keywords provided by Pfizer:
|
Alprazolam Tafil Xanax Bioequivalence Drug Kinetics |
Additional relevant MeSH terms:
|
Alprazolam Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013