|
|
|
|
|
|
Sponsored by: |
Mylan Pharmaceuticals |
Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00647894 |
The objective of this study was to investigate the bioequivalence of Mylan's alprazolam 1 mg Extended-release tablets to Pharmacia & Upjohn's Xanax XR 1 mg tablets following a single, oral 3 mg (3 x 1 mg) dose administered under fasting conditions.
Condition | Intervention | Phase |
Healthy |
Drug: Alprazolam Extended-Release Tablets 1 mg Drug: Xanax XR Tablets 1 mg |
Phase I |
ChemIDplus related topics: | Alprazolam |
Study Type: | Interventional |
Study Design: | Other, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Single-Dose Fasting In Vivo Bioequivalence Study of Alprazolam Extended-Release Tablets (1 mg; Mylan) to Xanax XR Tablets (1 mg; Pharmacia & Upjohn) in Healthy Volunteers |
Enrollment: | 24 |
Study Start Date: | January 2005 |
Study Completion Date: | January 2005 |
Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Alprazolam Extended-Release Tablets 1 mg
|
Drug: Alprazolam Extended-Release Tablets 1 mg |
2: Active Comparator
Xanax XR Tablets 1 mg
|
Drug: Xanax XR Tablets 1 mg |
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 must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormonal replacement therapies 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:
During the course of the study, from study screen until study exit - including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive device. Males must also use a spermicide containing barrier method of contraception to prevent the pregnancy of their sexual partners. These stipulations should be documented in the informed consent form.
3. Weight: At least 60 kg (132 lbs) for men and 24 kg (106 lbs) for women and all subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, Hepatitis B, Hepatitis C and HIV tests, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiate, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.
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:
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 |
Mylan Pharmaceuticals |
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-04118 |
First Received: | March 28, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00647894 |
Health Authority: | United States: Institutional Review Board |
|
|
|