An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following Various Sized Lunches As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers
Study Details
Study Description
Brief Summary
The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet following a 400 to 500 calorie, 600 to 750 calorie, or 800 to 1000 calorie medium-fat lunch as compared to pregabalin immediate release capsule 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following various sized lunches as compared to a single dose of the pregabalin immediate release capsule.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Detailed Description
Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR capsule
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Pregabalin controlled release, 330 mg, 400 to 500 calories
|
Drug: Pregabalin controlled release, 330 mg, 400 to 500 calories
A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie medium-fat lunch
|
Experimental: Pregabalin controlled release, 330 mg, 600 to 750 calories
|
Drug: Pregabalin controlled release, 330 mg, 600 to 750 calories
A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie medium-fat lunch
|
Experimental: Pregabalin controlled release, 330 mg, 800 to 1000 calories
|
Drug: Pregabalin controlled release, 330 mg, 800 to 1000 calories
A single oral dose of 330 mg controlled release tablet administered following an 800 to 1000 calorie medium-fat lunch
|
Other: Pregabalin immediate release, 300 mg Reference |
Drug: Pregabalin immediate release, 300 mg
A single oral dose of 300 mg immediate release capsule administered fasted
|
Outcome Measures
Primary Outcome Measures
- Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatments [3 days]
Secondary Outcome Measures
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [3 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy male or females
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Between the ages of 18 and 55 years, inclusive
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Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
Exclusion Criteria:
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Illicit drug use
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Pregnant or nursing females
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Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Pfizer Investigational Site | Overland Park | Kansas | United States | 66211 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A0081188