A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Study of Doxycycline Monohydrate 25 mg as a 5 mL Oral Suspension Under Fasting Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Teva Pharmaceuticals USA
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Doxycycline Monohydrate
Intervention: Doxycycline Monohydrate (Drug)
2
Vibramycin Monohydrate®
Intervention: Doxycycline Monohydrate (Drug)
Outcomes
Primary Outcomes
AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration.
Time Frame: 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.
Time Frame: Blood samples collected over a 72 hour period.
Bioequivalence based on AUC0-inf.
Cmax = Maximum Observed Concentration.
Time Frame: Blood samples collected over a 72 hour period.
Bioequivalence based on Cmax.
Secondary Outcomes
No secondary outcomes reported