- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01745575
Bioequivalence Trial of Alprazolam 2 mg Tablets
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
-
Study Plan
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:
Test product
Other Names:
|
Experimental: B(test)/A(reference)
initial administration of test and cross-over to reference
|
Reference product
Other Names:
Test product
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak Plasma Concentration (CMAX) of alprazolam
Time Frame: 0.0, 0.25, 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
|
Pharmacokinetics
|
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
|
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
|
Pharmacokinetics
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 116981
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.
Clinical Trials on Anxiety Disorders
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiRecruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Nazife Begüm KARANCompletedDental Anxiety | Sedative; Anxiety DisorderTurkey
-
Eli Lilly and CompanyCompletedAnxiety Neuroses | Anxiety States, Neurotic | Neuroses, AnxietyUnited States, Mexico, South Africa
-
West University of TimisoaraUnknownAnxiety Disorder/Anxiety StateRomania
-
Loyola UniversityCompletedAnxiety | Anxiety State | Procedural AnxietyUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)Active, not recruitingGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
University of MichiganBrain & Behavior Research FoundationNot yet recruitingGeneralized Anxiety Disorder | Anxiety | Social Anxiety Disorder | Panic DisorderUnited States
-
Saglik Bilimleri UniversitesiRecruiting
Clinical Trials on Alprazolam 2mg tablets
-
Otsuka Pharmaceutical Co., Ltd.Completed
-
E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.Not yet recruiting
-
Actavis Inc.Completed
-
Actavis Inc.CompletedHealthyUnited States
-
Marion CoeNational Institute on Drug Abuse (NIDA)Completed
-
Mylan Pharmaceuticals IncCompletedHealthyUnited States
-
Gannex Pharma Co., Ltd.RecruitingNon-alcoholic Fatty Liver Disease | Non-alcoholic SteatohepatitisChina