Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted In The Evening or Immediately Following A 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers
NCT01321671
Last updated date
ABOUT THIS STUDY
The purpose of this study is to evaluate the pharmacokinetics of a single dose of a
pregabalin controlled release (CR) tablet administered fasted in the evening relative to a
single dose of the CR tablet administered immediately following a 600 to 750 calorie evening
meal. The single dose pharmacokinetics of the pregabalin CR administered fed or fasted will
also be compared to the single dose pharmacokinetics of the pregabalin immediate release (IR)
capsule. In addition, the safety and tolerability of these 3 treatments will be evaluated.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Illicit drug use
- Pregnant or nursing females
- Females of childbearing potential who are unwilling or unable to use an acceptable
method of contraception
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
HealthyA Study To Asses Mass Balance And Absolute Bioavailability Of 14C PF-06826647 In Healthy Male Participants
NCT04591262
Male
18 Years+
years
MULTIPLE SITES
HealthyPharmacokinetics of Voriconazole in Obese Subjects
NCT01030653
- Paramus, New Jersey
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HealthyA Study to Determine the Bioequivalence of Two Doses of Tafamidis
NCT04575116
- New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HealthyStudy To Evaluate The Pharmacokinetic, Safety And Tolerability Of Single Or Multiple Subcutaneous Doses of Recifercept
NCT04543344
- Brussels, Bruxelles-capitale, Région DE
ALL GENDERS
21 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted In The Evening or Immediately Following A 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers | |||
| Official Title ICMJE | The Pharmacokinetics Of Pregabalin Controlled Release Formulation In Fed State Compared To The Controlled Release And Immediate Release Formulations In The Fasted State | |||
| Brief Summary | The purpose of this study is to evaluate the pharmacokinetics of a single dose of a pregabalin controlled release (CR) tablet administered fasted in the evening relative to a single dose of the CR tablet administered immediately following a 600 to 750 calorie evening meal. The single dose pharmacokinetics of the pregabalin CR administered fed or fasted will also be compared to the single dose pharmacokinetics of the pregabalin immediate release (IR) capsule. In addition, the safety and tolerability of these 3 treatments will be evaluated. | |||
| 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 Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) | |||
| Condition ICMJE | Healthy | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| Publications * | Chew ML, Plotka A, Alvey CW, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):617-26. doi: 10.1007/s40261-014-0211-4. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 24 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | June 2011 | |||
| Actual Primary Completion Date | June 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 55 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01321671 | |||
| Other Study ID Numbers ICMJE | A0081228 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | June 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||