Completed PHASE1 INTERVENTIONAL 2-arm NCT00658541

Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Tablets

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

Sponsor: Mutual Pharmaceutical Company, Inc.

Conditions Healthy Therapeutic Equivalency

Interventions Zolpidem Tartrate 10 mg tablet Zolpidem Tartrate 10 mg tablet (Ambien®)

Updated 6 times since 2017 Last updated: Apr 29, 2011 Started: May 31, 2004 Primary completion: May 31, 2004 Completion: May 31, 2004

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00658541, this PHASE1 trial focuses on Healthy and Therapeutic Equivalency and remains completed. Sponsored by Mutual Pharmaceutical Company, Inc., it has been updated 6 times since 2004, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

May 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Mutual Pharmaceutical Company, Inc.

Data source: Mutual Pharmaceutical Company, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.