An Investigation of the Absorption and Pharmacokinetics of Multiple Doses of Three Controlled Release Pregabalin Tablets as Compared to Multiple Doses of the Immediate Release Pregabalin Capsule
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01009541
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Healthy male or females
- Between the ages of 18 and 55 years, inclusive
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
Exclusion Criteria
- Illicit drug use
- Pregnant or nursing females
- Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Pregabalin controlled release, 165 mg Pregabalin controlled release, 165 mg - Pregabalin immediate release, 150 mg Pregabalin immediate release, 150 mg Reference Treatment Pregabalin controlled release, 330 mg Pregabalin controlled release, 330 mg - Pregabalin controlled release, 82.5 mg Pregabalin controlled release, 82.5 mg -
- Primary Outcome Measures
Name Time Method Minimum plasma concentration at steady-state within a dosing interval (Cmin) 5 days Maximum plasma concentration at steady-state (Cmax), time of Cmax at steady-state (tmax) 5 days The average plasma concentration at steady-state (Cav), half-life 5 days Peak:trough ratio at steady-state (PTR), peak to trough fluctuation at steady-state (PTF), and peak:trough swing at steady-state (PTS) 5 days Area under the curve at steady-state for a dosing interval (AUCτ), Dose-adjusted AUCτ 5 days
- Secondary Outcome Measures
Name Time Method Safety endpoints include evaluation of adverse events. 5 days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇧🇪Bruxelles, Belgium