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NCT00829790 · ClinicalTrials.gov registry record · Phase 1

Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fed Conditions

A Phase 1 study, sponsored by Teva Pharmaceuticals USA.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT00829790: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.

NCT00829790 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00829790, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

The objective of this study was to compare the rate of absorption and the oral bioavailability of a test formulation of doxycycline monohydrate 1 x 25 mg (5mL) oral suspension manufactured by IVAX Pharmaceuticals, Inc. and distributed by TEVA Pharmaceuticals USA to an equivalent oral dose of the commercially available reference product, Vibramycin Monohydrate® manufactured by Pfizer, Inc. Following an overnight fast of at least 10 hours, subjects consumed a standard high-calorie. high-fat breakfast meal. This standard breakfast meal began 30 minutes prior to each dose.

Primary Outcome

Bioequivalence based on Cmax.

Interventions

  • DRUG Doxycycline Monohydrate

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2006-10
Est. Completion 2006-10
Phase Phase 1
Teva Pharmaceuticals USA

83 total trials

What the finished NCT00829790 record still lists

NCT00829790 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

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

NCT00829790 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00829790 about?

NCT00829790 is a clinical study titled "Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fed Conditions". The objective of this study was to compare the rate of absorption and the oral bioavailability of a test formulation of doxycycline monohydrate 1 x 25 mg (5mL) oral suspension manufactured by IVAX Pharmaceuticals, Inc. and distributed by TEVA Pharmaceuticals USA to an equivalent oral dose of the com...

What is the current status of trial NCT00829790?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2006-10. Estimated completion is 2006-10.

What interventions are being tested in trial NCT00829790?

The interventions under investigation include: Doxycycline Monohydrate (DRUG).

Who is sponsoring clinical trial NCT00829790?

This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00829790's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00829790, the US trial registry maintained by the National Library of Medicine. NCT00829790 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.