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| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| 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 |
|
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 |