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Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien Tablets
This study has been completed.
First Received: April 9, 2008   Last Updated: May 24, 2008   History of Changes
Sponsor: Mutual Pharmaceutical Company, Inc.
Information provided by: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT00658541
  Purpose

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


Condition Intervention Phase
Healthy
Therapeutic Equivalency
Drug: zolpidem tartrate
Phase I

Study Type: Interventional
Study Design: Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title: 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 Healthy Adult Subjects

Resource links provided by NLM:


Further study details as provided by Mutual Pharmaceutical Company, Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: two weeks ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: May 2004
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
One tablet containing 10mg test product to be administered at hour 0 on Day 1 of each test period
Drug: zolpidem tartrate
10 mg tablet
B: Active Comparator
One Ambien tablet containing 10mg reference drug to be administered at hour 0 on Day 1 of each test period
Drug: zolpidem tartrate
10 mg tablet

  Eligibility

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

Inclusion Criteria:

  • male or female
  • at least 18 years of age
  • 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, complete physical examination, and laboratory tests, all within four (4) weeks prior to study start. The subject may not have a history of significant past illness expected to affect the investigation
  • subjects must read and sign 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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Mutual Pharmaceutical ( Kristin Arnold, Vice President R&D )
Study ID Numbers: 04065
Study First Received: April 9, 2008
Last Updated: May 24, 2008
ClinicalTrials.gov Identifier: NCT00658541     History of Changes
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2009