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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

Last updated on October 4, 2018

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Study Location
Pfizer Investigational Site
Overland Park, Kansas, 66211 United States
Contact
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
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

NCT01270815
Pfizer
Completed
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

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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
An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Pregabalin Controlled Release Formulation Administered At Lunch Following Various Caloric Intakes As Compared To The Immediate Release Formulation
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.
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
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy
  • 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
  • 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
  • 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
  • Drug: Pregabalin immediate release, 300 mg
    A single oral dose of 300 mg immediate release capsule administered fasted
  • Experimental: Pregabalin controlled release, 330 mg, 400 to 500 calories
    Intervention: Drug: Pregabalin controlled release, 330 mg, 400 to 500 calories
  • Experimental: Pregabalin controlled release, 330 mg, 600 to 750 calories
    Intervention: Drug: Pregabalin controlled release, 330 mg, 600 to 750 calories
  • Experimental: Pregabalin controlled release, 330 mg, 800 to 1000 calories
    Intervention: Drug: Pregabalin controlled release, 330 mg, 800 to 1000 calories
  • Pregabalin immediate release, 300 mg
    Reference
    Intervention: Drug: Pregabalin immediate release, 300 mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
April 2011
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01270815
A0081188
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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