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Sponsored by: |
Mylan Pharmaceuticals |
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Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00650299 |
The objective of this study was to investigate the bioequivalence of Mylan's alprazolam Extended-release 3 mg tablets to Pharmacia & Upjohn's Xanax XR® 3 mg tablets following a single, oral 3 mg (1 x 3 mg) dose administered under fed conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Alprazolam Extended-release Tablets 3 mg Drug: Xanax XR® Tablets 3 mg |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Single-Dose Food In Vivo Bioequivalence Study of Alprazolam Extended-Release Tablets (3 mg; Mylan) to Xanax XR® Tablets (3 mg; Pharmacia & Upjohn) in Healthy Volunteers |
Enrollment: | 21 |
Study Start Date: | August 2004 |
Study Completion Date: | August 2004 |
Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Alprazolam Extended-release Tablets 3 mg
|
Drug: Alprazolam Extended-release Tablets 3 mg
3mg, single dose fed
|
2: Active Comparator
Xanax XR® Tablets 3 mg
|
Drug: Xanax XR® Tablets 3 mg
3mg, single dose fed
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female.
Women of childbearing potential must practice abstinence or use an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormone replacement therapy are permitted in this study. Acceptable forms of contraception include the following:
Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
(1) postmenopausal with an absence of menses for at least one (1) year, or (2) bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or (3) total hysterectomy
Exclusion Criteria:
1. Institutionalized subjects will not be used. 2. Social Habits:
Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
4. Diseases:
A positive HIV, Hepatitis B or Hepatitis C test.
5. Abnormal and clinically significant laboratory test results:
Abnormal and clinically relevant ECG tracing. 6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
8. Allergy or hypersensitivity to alprazolam, other benzodiazepines, lactose, magnesium stearate, colloidal silicon dioxide, hypromellose or D & C Yellow No. 10. 9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
10. History of acute narrow angle glaucoma 11. Consumption of grapefruit or any grapefruit containing products within 7 days of drug administration.
United States, West Virginia | |
Kendle International Inc. | |
Morgantown, West Virginia, United States, 26505 |
Principal Investigator: | Dorian Williams, M.D. | Kendle International Inc. |
Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
Study ID Numbers: | ALPR-0467 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00650299 History of Changes |
Health Authority: | United States: Institutional Review Board |
Neurotransmitter Agents Tranquilizing Agents Alprazolam Hypnotics and Sedatives |
Psychotropic Drugs Central Nervous System Depressants Anti-Anxiety Agents Healthy |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants |
Pharmacologic Actions Alprazolam Therapeutic Uses Hypnotics and Sedatives GABA Agents Anti-Anxiety Agents Central Nervous System Agents |