Bioequivalence Study of Zolpidem 10 mg Tablets Under Fed Conditions

Completed · Not applicable

Conditions studied: Healthy

In brief

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 non-fasting conditions

Key facts

Study ID

NCT00779441

Run by

Ranbaxy Laboratories Limited

People needed

36

Starts

2005-08-01

Expected to finish

2005-11-01

Last updated by the study team

2008-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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
• Volunteers 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 b y 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 breast 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
• Volunteers who reported taking any systemic prescription 14 days prior to Period I dosing

Where it is running

• PRACS Institute Ltd. — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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