Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00601666 · ClinicalTrials.gov registry record · NA

Bioequivalency Study of Zolpidem Tartrate Under Fasting Conditions

A NA study, sponsored by Roxane Laboratories.

Completed
Registry status
NA
Development phase
30
Enrollment target

NCT00601666 is a NA study that has completed, run by Roxane Laboratories. The registered enrollment target is 30 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00601666, a NA study, has completed, sponsored by Roxane Laboratories.

COMPLETED
Registry status
NA
Development phase
30 participants
Enrollment target

Study Summary

The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Interventions

  • DRUG Zolpidem

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2004-03
Est. Completion 2004-03
Phase NA

Sponsor

Roxane Laboratories

93 total trials

What the Registry Record Tells You About NCT00601666

The ClinicalTrials.gov registry entry for NCT00601666 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roxane Laboratories, which has 93 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Zolpidem is the first listed.

NCT00601666 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00601666 about?

NCT00601666 is a clinical study titled "Bioequivalency Study of Zolpidem Tartrate Under Fasting Conditions". The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

What is the current status of trial NCT00601666?

This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2004-03. Estimated completion is 2004-03.

What interventions are being tested in trial NCT00601666?

The interventions under investigation include: Zolpidem (DRUG).

Who is sponsoring clinical trial NCT00601666?

This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.