Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate
Phase 4
Completed
- Conditions
- Bacterial Infection
- Interventions
- Registration Number
- NCT00939562
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- Healthy male subjects between the ages of 18 and 55 years.
- Body Mass Index (BMI) of 18 to 30 kg/m2.
Exclusion Criteria
- Evidence or history of clinically significant abnormality.
- Any condition possibly affecting drug absorption.
- A positive urine drug screen.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description doxycycline monohydrate tablet doxycycline monohydrate tablet - doxycycline carragenate tablet doxycycline carragenate tablet -
- Primary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) of Doxycycline 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose. Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose. AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇮🇳Ahmedabad, Gujarat, India