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

NCT00829790 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-19

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Doxycycline Monohydrate

25 mg 5mL oral dose

DRUG

Doxycycline Monohydrate

25 mg 5 mL dose

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Frederick A Bieberdorf, M.D. · CEDRA Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2006-10-31
Completion
2006-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00829790 on ClinicalTrials.gov