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NCT00694187 · ClinicalTrials.gov registry record · NA

Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions

A NA study, sponsored by Roxane Laboratories.

Completed
Registry status
NA
Development phase
39
Enrollment target

NCT00694187: Completed NA study, sponsored by Roxane Laboratories.

NCT00694187 is a NA study that has completed, run by Roxane Laboratories. The registered enrollment target is 39 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00694187, a NA study, has completed, sponsored by Roxane Laboratories.

COMPLETED
Registry status
NA
Development phase
39 participants
Enrollment target

Study Summary

The objective of this study was to show the bioequivalence of a Roxane Laboratories' Zaleplon Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design

Interventions

  • DRUG Zaleplon

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2004-01
Est. Completion 2004-02
Phase NA
Roxane Laboratories

93 total trials

What the finished NCT00694187 record still lists

NCT00694187 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

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

NCT00694187 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00694187 about?

NCT00694187 is a clinical study titled "Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions". The objective of this study was to show the bioequivalence of a Roxane Laboratories' Zaleplon Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design

What is the current status of trial NCT00694187?

This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2004-01. Estimated completion is 2004-02.

What interventions are being tested in trial NCT00694187?

The interventions under investigation include: Zaleplon (DRUG).

Who is sponsoring clinical trial NCT00694187?

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

How this trial's enrollment target compares

Where NCT00694187's enrollment target sits among peer trials

39 1536th of 2000 higher than 463 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00694187, the US trial registry maintained by the National Library of Medicine. NCT00694187 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.