Bioequivalence Trial of Alprazolam 0.5 mg Tablets

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01745562
First received: December 6, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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

Test product was Zamoprax® 0.5 mg (GlaxoSmithKline) and reference product Tafil® 0.5 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.


Condition Intervention Phase
Anxiety Disorders
Drug: Alprazolam 0.5 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Study With Single Dosage of Two Oral Preparations of Alprazolam 0.5 mg Alprazolam (Zamoprax GlaxoSmithKline México, S.A. de C.V. vs. Tafil 0.5mg, Pharmacia &Upjohn, S.A. de C.V.) in Fasting Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Pharmacokinetics

  • 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 ] [ Designated as safety issue: No ]
    Pharmacokinetics


Enrollment: 28
Study Start Date: December 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A(reference)/B(test)
initial administration of reference and cross-over to test
Drug: Alprazolam 0.5 mg
Reference product
Other Name: Tafil 0.5 mg Pfizer Pharmaceuticals LLC
Drug: Alprazolam 0.5 mg
Test product
Other Name: Zamoprax 0.5 mg GLAXOSMITHKLINE MEXICO SA de CV
Experimental: B(test)/A(reference)
initial administration of test and cross-over to reference
Drug: Alprazolam 0.5 mg
Reference product
Other Name: Tafil 0.5 mg Pfizer Pharmaceuticals LLC
Drug: Alprazolam 0.5 mg
Test product
Other Name: Zamoprax 0.5 mg GLAXOSMITHKLINE MEXICO SA de CV

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 antibiotic or non-steroidal anti-inflammatory analgesic. 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. Positive pregnancy test or antidoping test Special diet requirement, for instance vegetarian diet. Inability to understand nature, aims, and possible consequences of the study. Evidence of non-cooperative attitude during the study. Breast-feeding. Females on contraceptive hormonal treatment.

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01745562

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01745562     History of Changes
Other Study ID Numbers: 116977
Study First Received: December 6, 2012
Last Updated: December 6, 2012
Health Authority: Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)

Keywords provided by GlaxoSmithKline:
Alprazolam
Anxiety disorders
Bioequivalence
Mexico

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
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 September 16, 2014