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Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Tablets

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ClinicalTrials.gov Identifier: NCT00658541
Recruitment Status : Completed
First Posted : April 15, 2008
Results First Posted : January 20, 2010
Last Update Posted : May 3, 2011
Sponsor:
Information provided by:
Mutual Pharmaceutical Company, Inc.

Tracking Information
First Submitted Date  ICMJE April 9, 2008
First Posted Date  ICMJE April 15, 2008
Results First Submitted Date  ICMJE December 16, 2009
Results First Posted Date  ICMJE January 20, 2010
Last Update Posted Date May 3, 2011
Study Start Date  ICMJE May 2004
Actual Primary Completion Date May 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2011)
  • Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate [ Time Frame: serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration ]
    The maximum or peak concentration that zolpidem tartrate reaches in the plasma.
  • Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Zolpidem Tartrate [ Time Frame: serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration ]
    The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable zolpidem tartrate concentration (t), as calculated by the linear trapezoidal rule.
  • Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]for Zolpidem Tartrate [ Time Frame: serial pharmacokinetic blood samples drawn prior to dosing (hour 0), then 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration ]
    The area under the zolpidem tartrate plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2008)
Bioequivalence [ Time Frame: two weeks ]
Change History Complete list of historical versions of study NCT00658541 on ClinicalTrials.gov Archive Site
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 Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Tablets
Official Title  ICMJE A Randomized, Two-way Crossover, Single-dose, Open-label Study to Evaluate the Relative Bioequivalence of a Test Tablet Formulation of Zolpidem Tartrate 10mg, Compared to an Equivalent Dose of Ambien® in Fed, Healthy, Adult Subjects
Brief Summary The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available Ambien® (zolpidem tartrate tablets)in adult subjects under fed conditions.
Detailed Description

The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available Ambien® (zolpidem tartrate tablets)in adult subjects under fed conditions.

Thirty-eight healthy, non-smoking, non-obese male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two zolpidem tartrate dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, following an overnight fast of at least 10 hours and a standardized, high fat breakfast, subjects will receive either a single oral dose of the test formulation, zolpidem tartrate (1 x 10 mg tablet) or a single oral dose of the reference formulation, Ambien® (1 x 10 mg tablet). After a 7 day washout period, on the morning of Day 8 following an overnight fast of at least 10 hours and a standardized, high fat breakfast, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 12 hours post dose at times sufficient to adequately define the pharmacokinetics of zolpidem tartrate. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drugs and/or procedures. Blood pressure and pulse rate will be obtained prior to dosing and at 0.5, 1, 2, 4 and 12 hours post-dose. All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Healthy
  • Therapeutic Equivalency
Intervention  ICMJE
  • Drug: Zolpidem Tartrate 10 mg tablet
    10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.
  • Drug: Zolpidem Tartrate 10 mg tablet (Ambien®)
    10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.
    Other Name: Ambien®
Study Arms  ICMJE
  • Experimental: Zolpidem Tartrate 10 mg Tablets
    A single dose of zolpidem tartrate 10 mg administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.
    Intervention: Drug: Zolpidem Tartrate 10 mg tablet
  • Active Comparator: Zolpidem Tartrate (Ambien®) 10 mg Tablets
    A single dose of Ambien® 10 mg administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.
    Intervention: Drug: Zolpidem Tartrate 10 mg tablet (Ambien®)
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: April 14, 2008)
38
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2004
Actual Primary Completion Date May 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Sex: Male or Female; similar proportions of each preferred
  • Age: At least 18 years
  • Weight: must be 15% of ideal weight for height and frame
  • Subjects must be in good health and physical condition as determined by medical history
  • Subjects must read and sign the Consent Form

Exclusion Criteria:

  • history of treatment for alcoholism, substance abuse, or drug abuse within past 24 months
  • history of malignancy, stroke, diabetes, cardiac, renal or liver disease
  • history of GERD, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease
  • history of treatment for asthma within the past five (5) years
  • history of mental depression, pulmonary disease, sleep apnea
  • females who are pregnant or lactating
  • history of hypersensitivity to zolpidem tartrate, or any hypnotic or sedative
  • conditions upon screening which might contraindicate or require that caution be used in the administration of zolpidem tartrate, including sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm Hg; heart rate less than 50 beats per minute after a 5-minute rest in a seated position
  • inability to read and/or sign the consent form
  • treatment with any other investigation drug during the four (4) weeks prior to the initial dosing for this study
  • subjects who have donated blood within four (4) weeks prior to the initial dosing for this study
  • subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums, etc.) Three (3) months abstinence is required.
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00658541
Other Study ID Numbers  ICMJE 04065
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kristin Arnold, Vice President R&D, Mutual Pharmaceutical
Study Sponsor  ICMJE Mutual Pharmaceutical Company, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mutual Pharmaceutical Company, Inc.
Verification Date April 2011

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