Bioequivalence Trial of Alprazolam 0.25 mg Tablets

June 12, 2017 updated by: GlaxoSmithKline

Open,Two-period, Two-treatment, Two-sequence, Cross-over, Randomized Trial of Single Doses of Two Oral Preparations With 0.25 mg of Alprazolam (Zamoprax® GlaxoSmithKline México, S.A. de C.V. vs. Tafil® 0.25mg, Pharmacia &Upjohn, S.A. de C.V.) in Fasting Healthy Volunteers

The objective of this study was to confirm if two formulations of alprazolam (tablets) are bioequivalent.

Test product was Zamoprax® 0.25 mg (GlaxoSmithKline) and reference product Tafil® 0.25 mg (Pharmacia & Upjohn). One tablet was the single dosage.

The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.

The population was composed of 28 healthy volunteers, both genders, adults between 18-50 years.

The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.
  • Healthy, between 18 and 50 years.
  • Body Mass Index between 18 and 27.5
  • In good health by complete medical history and laboratory tests.
  • Blood pressure 130-90/ 90-60 mm Hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute.
  • Laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, Hepatitis B and C antigens, HIV, urinalysis, anti-doping, pregnancy, electrocardiogram

Exclusion Criteria:

  • Alteration of vital signs
  • Not complying with inclusion criteria
  • History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. Those suffering from muscular trauma 21 days before the beginning of the study.
  • Requirement of any kind of medication during the course of the study, except study medication.
  • History of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer.
  • Exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning.
  • Administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study.
  • Hospitalization for any cause in the seven months before the beginning of the study.
  • Administration of investigational drugs in the 60 days before the study.
  • Allergy to any medication, food, or substance.
  • Alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study.
  • Blood donation or loss => 450 ml in the 60 days before the beginning of the study.
  • History of drug or alcohol abuse.
  • Special diet requirement, for instance vegetarian diet.
  • Inability to understand nature, aims, and possible consequences of the study.
  • Non-cooperative attitude during the study.
  • Positive anti-doping or pregnancy test.
  • Breast-feeding.
  • Females on hormonal treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A (reference)/ B (test)
initial administration of reference and cross-over to test
Reference product
Other Names:
  • Tafil®
  • Pharmacia & Upjohn
Test product
Other Names:
  • Zamoprax®
  • GlaxoSmithKline
Experimental: B (test)/ A (reference)
initial administration of test and cross-over to reference
Reference product
Other Names:
  • Tafil®
  • Pharmacia & Upjohn
Test product
Other Names:
  • Zamoprax®
  • GlaxoSmithKline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration (CMAX) of alprazolam
Time Frame: 0.0, 0.167, 0.333, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 9.0, 12.0, 18.0, 22.0, 36.0, 48.0, 60.0, and 72.0 hours postdosage
Pharmacokinetics
0.0, 0.167, 0.333, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 9.0, 12.0, 18.0, 22.0, 36.0, 48.0, 60.0, and 72.0 hours postdosage
Area under the plasma concentration versus time curve (AUC) of alprazolam
Time Frame: 0.0, 0.167, 0.333, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 9.0, 12.0, 18.0, 22.0, 36.0, 48.0, 60.0, and 72.0 hours postdosage
Pharmacokinetcis
0.0, 0.167, 0.333, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 9.0, 12.0, 18.0, 22.0, 36.0, 48.0, 60.0, and 72.0 hours postdosage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2010

Primary Completion (Actual)

December 10, 2010

Study Completion (Actual)

December 10, 2010

Study Registration Dates

First Submitted

November 28, 2012

First Submitted That Met QC Criteria

May 9, 2013

First Posted (Estimate)

May 15, 2013

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 12, 2017

Last Verified

June 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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