A Study To Assess The Pharmacokinetics, Safety, And Tolerability Of A Pregabalin Controlled Release Formulation Administered Following Various Sized Caloric Meals As Compared To The Pregabalin Immediate Release Formulation
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01080612
First received: February 26, 2010
Last updated: July 6, 2010
Last verified: July 2010
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Purpose
The purpose of this study is to (1) evaluate the effect of caloric intake on the pharmacokinetics of a single dose of a 330 mg pregabalin controlled release tablet relative to a 300 mg pregabalin immediate release capsule administered fasted and (2) determine the safety and tolerability of a single dose of a 330 mg pregabalin controlled release formulation administered following various sized caloric meals and the 300 mg pregabalin immediate release capsule administered fasted.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: 330 mg pregabalin controlled release Drug: 300 mg pregabalin immediate release |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Pregabalin Controlled Release Formulation Administered Following Various Caloric Intakes As Compared To The Immediate Release Formulation |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Pregabalin area under the curve (AUC) from time of study drug administration to the last quantifiable plasma concentration (AUClast) and to infinity (AUCinf) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse events, vital signs, and clinical safety laboratories. [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 24 |
| Study Start Date: | April 2010 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 330 mg pregabalin controlled release: 400 to 500 calories |
Drug: 330 mg pregabalin controlled release
A single dose of 330 mg controlled release tablet will be administered following a 400 to 500 calorie meal
|
| Experimental: 330 mg pregabalin controlled release: 600 to 750 calories |
Drug: 330 mg pregabalin controlled release
A single dose of 330 mg controlled release tablet will be administered following a 600 to 750 calorie meal
|
| Experimental: 330 mg pregabalin controlled release: 800 to 1000 calories |
Drug: 330 mg pregabalin controlled release
A single dose of 330 mg controlled release tablet will be administered following an 800 to 1000 calorie meal
|
| 300 mg pregabalin immediate release |
Drug: 300 mg pregabalin immediate release
A single dose of 300 mg immediate release capsule will be administered in the fasted state
|
Detailed Description:
To assess the single dose pharmacokinetics, safety, and tolerability of pregabalin controlled release formulation following various sized caloric meals relative to the immediate release formulation.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01080612 History of Changes |
| Other Study ID Numbers: | A0081239 |
| Study First Received: | February 26, 2010 |
| Last Updated: | July 6, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
pregabalin pharmacokinetics bioavailability |
Additional relevant MeSH terms:
|
Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 23, 2013