Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01270815
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01270815
Recruitment Status : Completed
First Posted : January 5, 2011
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE January 4, 2011
First Posted Date  ICMJE January 5, 2011
Last Update Posted Date January 22, 2021
Study Start Date  ICMJE March 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2011)
Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatments [ Time Frame: 3 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2011)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
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
 (submitted: January 4, 2011)
28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 NCT01270815
Other Study ID Numbers  ICMJE A0081188
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP