Last updated: 11/03/2018 19:48:09

Bioequivalence trial of Alprazolam 0.25 mg tablets

GSK study ID
116937
See study documents
Clinicaltrials.gov ID
NCT01853956
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: 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.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Peak Plasma Concentration (CMAX) of alprazolam

Timeframe: 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

Timeframe: 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

Secondary outcomes:
Not applicable
Interventions:
Drug: Alprazolam 0.25 mg
Enrollment:
28
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Anxiety Disorders
Product
GR40370
Collaborators
Not applicable
Study date(s)
December 2010 to December 2010
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
  • Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.
  • Healthy, between 18 and 50 years.
  • Alteration of vital signs
  • Not complying with inclusion criteria
Inclusion and exclusion 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 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.

Trial location(s)

No location data available.

Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2010-10-12

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
Results for study 116937 can be found on the GSK Clinical Study Register.
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