Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fasting Conditions
- Registration Number
- NCT00829764
- Lead Sponsor
- Teva Pharmaceuticals USA
- Brief Summary
The objective of this single-dose, open-label, randomized, two-period crossover study was to compare the rate of absorption and 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.
- Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Doxycycline Monohydrate Doxycycline Monohydrate 2 Doxycycline Monohydrate Vibramycin Monohydrate®
- Primary Outcome Measures
Name Time Method AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration. Blood samples collected over a 72 hour period. Bioequivalence based on AUC0-t.
AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity. Blood samples collected over a 72 hour period. Bioequivalence based on AUC0-inf.
Cmax = Maximum Observed Concentration. Blood samples collected over a 72 hour period. Bioequivalence based on Cmax.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CEDRA Clinical Research
🇺🇸San Antonio, Texas, United States
CEDRA Clinical Research🇺🇸San Antonio, Texas, United States