Bioequivalence Study of Zolpidem 10mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00779051
First received: October 23, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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


Condition Intervention
Healthy
Drug: Zolpidem 10mg tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: An Open Label, Relative Bioavailability Study of 10 mg Zolpidem Tablet Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: August 2005
Study Completion Date: October 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Zolipidem 10mg tablets of Ranbaxy
Drug: Zolpidem 10mg tablets
Active Comparator: 2
Ambien® 10mg tablets
Drug: Zolpidem 10mg tablets

Detailed Description:

This was a single-center, randomized, open label, two-way cross over study conducted under fasting conditions. Subjects checked into the clinical facility the day prior to dosing at least 10 hours prior to dose administration. On study day 1, subjects were dosed with single oral dose (1x10mg tablet) of the test and reference products thirty minutes after initiation of a standardized, high fat breakfast which was preceded by an overnight fast. Following a seven day wash out period, subjects returned and were dosed with an alternative treatment as per randomization

Thirty-six (N=36) volunteers were enrolled in the study. Subject 07 elected to withdraw foe personal reasons prior to period II check in. Subject 22 was excluded from statistical analysis due to emesis before twice the median Tmax of reference product

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy men or women 18 years of age or older at the time of dosing
  2. Weights within ±20% for height and body frame as per Desirable weight for adults(1983 Metropolitan Height and Weight table)
  3. Volunteers judged by the investigator to be healthy based on their medical and medication history, physical examination, electrocardiogram, and clinical laboratory results
  4. Vounteers willing to participate in the study and have signed a copy of written consent form
  5. 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)

Exclusion Criteria:

Subject candidates must not be enrolled in the study if they meet any of the following criteria:

  1. Volunteers with a recent history of drug or alcohol addiction or abuse
  2. 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)
  3. Volunteers with clinical laboratory test values outside the accepted reference range and, when confirmed on re-examination, were deemed to by clinically significant
  4. Volunteers with a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody
  5. Volunteers with positive drug abuse screen when screened for the study
  6. Female volunteers demonstrating a positive pregnancy screen
  7. Female volunteers who are currently bre ast feeding
  8. Volunteers with a history of clinically significant allergies including the allergies
  9. Volunteers with any clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigation)
  10. Volunteers who currently use tobacco products
  11. Volunteers who had taken any drug known to induce metabolism or inhibit hepatic metabolism in the 28 days prior to the period I dosing.
  12. 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
  13. 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
  14. Volunteers who reported receiving any investigational drug within 28 days prior to period I dosing
  15. Volunteers who reported taking any systemic prescription 14 days prior to Period I dosing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779051

Locations
United States, North Dakota
PRACS Institute Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Research Labs
ClinicalTrials.gov Identifier: NCT00779051     History of Changes
Other Study ID Numbers: R05-274
Study First Received: October 23, 2008
Last Updated: October 23, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Ranbaxy Inc.:
Bioequivalence Zolpidem 10mg tablets

Additional relevant MeSH terms:
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014