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Trial record 23 of 137 for:    ZOLPIDEM

Bioequivalence Study of Zolpidem 10 mg Tablets Under Fed Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00779441
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : October 24, 2008
Sponsor:
Information provided by:
Ranbaxy Inc.

Tracking Information
First Submitted Date  ICMJE October 23, 2008
First Posted Date  ICMJE October 24, 2008
Last Update Posted Date October 24, 2008
Study Start Date  ICMJE August 2005
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2008)
Bioequivalence
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of Zolpidem 10 mg Tablets Under Fed Conditions
Official Title  ICMJE An Open Label, Relative Bioavailability Study of 10 mg Zolpidem Tablet Under Non-Fasting Conditions
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 non-fasting conditions
Detailed Description This was a single-center, randomized, open label, two-way cross over study conducted under non-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 of which 17 were females and 19 were males. Subject 22 was dropped from further study participation prior to period II check in due to adverse events
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Zolpidem 10mg tablets
Study Arms  ICMJE
  • Experimental: 1
    Zolpidem 10mg tablets of ranbaxy
    Intervention: Drug: Zolpidem 10mg tablets
  • Active Comparator: 2
    Ambien® 10mg tablets
    Intervention: Drug: Zolpidem 10mg tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2008)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2005
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. Volunteers 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 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)

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 breast 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00779441
Other Study ID Numbers  ICMJE R05-275
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Tausif monif, Ranbaxy Research labs
Study Sponsor  ICMJE Ranbaxy Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ranbaxy Inc.
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP