Bioequivalence Study of Zolpidem 10mg Tablets Under Fasting Conditions

NCT00779051 | Completed DMC

• 1 other identifier: R05-274
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The study compared the relative bioavailability (rate and extent of absorption) of 10 mg Zolpidem tablets by Ohm Laboratories Inc. with that of 10 mg Ambien® tablets distributed by Sanofi-Synthelabo, Inc. following single oral dose (1x10 mg tablet) in healthy adult volunteers administered under fasting condition

Conditions

Healthy

Keywords

Bioequivalence Zolpidem 10mg tablets

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

Study Arms (2)

1

EXPERIMENTAL

Zolipidem 10mg tablets of Ranbaxy

Drug: Zolpidem 10mg tablets

2

ACTIVE COMPARATOR

Ambien® 10mg tablets

Drug: Zolpidem 10mg tablets

Interventions

Zolpidem 10mg tablets DRUG

1; 2

Eligibility Criteria

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

You may qualify if:

• Healthy men or women 18 years of age or older at the time of dosing
• Weights within ±20% for height and body frame as per Desirable weight for adults(1983 Metropolitan Height and Weight table)
• Volunteers judged by the investigator to be healthy based on their medical and medication history, physical examination, electrocardiogram, and clinical laboratory results
• Vounteers willing to participate in the study and have signed a copy of written consent form
• If female:
• Of childbearing potential, was practicing an acceptable method of birth control for the duration of study as judged by the investigator(s), such as condom with spermicide, intrauterine device (IUD), or abstinence; or Was menopausal for at least 1year; or Was surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

You may not qualify if:

• Subject candidates must not be enrolled in the study if they meet any of the following criteria:
• Volunteers with a recent history of drug or alcohol addiction or abuse
• Volunteers with the presence of clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators)
• Volunteers with clinical laboratory test values outside the accepted reference range and, when confirmed on re-examination, were deemed to by clinically significant
• Volunteers with a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody
• Volunteers with positive drug abuse screen when screened for the study
• Female volunteers demonstrating a positive pregnancy screen
• Female volunteers who are currently bre ast feeding
• Volunteers with a history of clinically significant allergies including the allergies
• Volunteers with any clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigation)
• Volunteers who currently use tobacco products
• Volunteers who had taken any drug known to induce metabolism or inhibit hepatic metabolism in the 28 days prior to the period I dosing.
• Volunteers who reported donating greater than 150 mL of blood within 28 days prior to period I dosing. All subjects were advised not to donate plasma for four weeks after completing the study
• Volunteers who had donated plasma (e.g. plasmapheresis) within 14 days prior to period I dosing. All subjects were advised not to donate plasma for four weeks after completing o the study
• Volunteers who reported receiving any investigational drug within 28 days prior to period I dosing

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

PRACS Institute Ltd.

Fargo, North Dakota, 58104, United States

Location

Related Links

• Related Info
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MeSH Terms

Interventions

Zolpidem

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: August 1, 2005
• Primary Completion: September 1, 2005
• Study Completion: October 1, 2005
• Last Updated: October 24, 2008

Record last verified: 2008-10

Locations

US (1)