Bioequivalence Trial of Alprazolam 2 mg Tablets
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Purpose
The objective of this study was to confirm if two formulations of alprazolam (tablets) are bioequivalent.
Test product was Zamoprax® 2 mg (GlaxoSmithKline) and reference product Tafil® 2 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 26 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 2mg tablets Drug: Alprazolam 2 mg tablets |
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 Trial With Single Dosageof Two Oral Preparations Containing 2 mg of Alprazolam (Zamoprax GlaxoSmithKline México, S.A. de C.V. vs. Tafil 2.0 mg, Pharmacia &Upjohn, S.A. de C.V.) in Fasting Healthy Volunteers |
- Peak Plasma Concentration (CMAX) of alprazolam [ Time Frame: 0.0, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 9.0, 12.0, 18.0, 22.0, 36.0, 48.0,and 60.0 hours postdosage ] [ Designated as safety issue: No ]Pharmacokinetics
- Area under the plasma concentration versus time curve (AUC) of alprazolam [ Time Frame: 0.0, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 9.0, 12.0, 18.0, 22.0, 36.0, 48.0,and 60.0 hours postdosage ] [ Designated as safety issue: No ]Pharmacokinetics
| Enrollment: | 26 |
| Study Start Date: | March 2010 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 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 2mg tablets
Reference product
Other Name: Tafil 2 mg Pharmacia & Upjohn SA de CV
Drug: Alprazolam 2 mg tablets
Test product
Other Name: Zamoprax 2 mg GlaxoSmithKline Mexico SA de CV
|
|
Experimental: B(test)/A(reference)
initial administration of test and cross-over to reference
|
Drug: Alprazolam 2mg tablets
Reference product
Other Name: Tafil 2 mg Pharmacia & Upjohn SA de CV
Drug: Alprazolam 2 mg tablets
Test product
Other Name: Zamoprax 2 mg GlaxoSmithKline Mexico SA de CV
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.
Healthy, between 18 and 40 years. Body Mass Index between 19 and 27 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 one week study beginning up to the las blood sample.
Blood donation or loss => 450 ml in the 60 days before the beginning of the study.
History of alcohol abuse. Use of products containing tobacco, or excess of nicotine, equivalent to five cigarettes per day.
Positive pregnancy test or breast-feeidg. 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. Female volunteers on oral contraceptives.
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Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01745575 History of Changes |
| Other Study ID Numbers: | 116981 |
| 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:
|
Bioequivalence Alprazolam Anxiety disorders 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 June 18, 2013