Fasting Study of Alprazolam Extended-Release Tablets 1 mg to Xanax XR Tablets 1 mg

NCT00647894 | Completed Phase 1

• 1 other identifier: ALPR-04118
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

  within 30 days

Study Arms (2)

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

Interventions

Alprazolam Extended-Release Tablets 1 mg DRUG

1

Xanax XR Tablets 1 mg DRUG

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female.
• Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on weekends, the HCG pregnancy test should be given within 24 hours prior to dosing of each study period. An additional serum (beta-HCG) pregnancy test will be performed upon completion of the study.
• 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:
• intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
• barrier methods containing or used in conjunction with a spermicidal agent, or
• surgical sterilization
• Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
• postmenopausal with an absence of menses for at least one (1) year, or
• bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
• total hysterectomy
• 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.
• \. 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).
• \. 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.

You may not qualify if:

• \. Institutionalized subjects will not be used. 2. Social Habits:
• Use of any tobacco products within 1 year of the start of the study.
• Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within 24 hours prior to the initial dose of study medication.
• Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
• Any recent, significant change in dietary or exercise habits.
• A positive test for any drug included in the urine drug screen.
• History of drug and/or alcohol abuse. 3. Medications:
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• Use of any prescription or over-the-counter (OTC) medications within 14 days prior to the initial dose of study medication.
• Use of any hormonal contraceptives and hormone replacement therapy within 3 months prior to study medication dosing.
• Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
• \. Diseases:
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• History of any significant chronic disease and/or hepatitis.
• Acute illness at the time of either the pre-study medical evaluation or dosing.

Sponsors & Collaborators

• Mylan Pharmaceuticals Inc: lead

Study Sites (1)

Kendle International Inc.

Morgantown, West Virginia, 26505, United States

Location

Related Links

• Mylan Pharmaceuticals Inc. - Clinical Trial Results
• Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use
• Recalls, Market Withdrawals and Safety Alerts

MeSH Terms

Interventions

Alprazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dorian Williams, M.D.

  Kendle International Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 28, 2008
• First Posted: April 1, 2008
• Study Start: January 1, 2005
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

US (1)