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Investigation Of How PD 0332334 And Metformin Are Eliminated From The Body When They Are Administered At The Same Time

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NCT00809536

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Generalized Anxiety Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Nonsmokers

- Male or female adults

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Current or history of significant medical illness

- Smokers

- Illicit drug use

NCT00809536
Pfizer
Terminated
Investigation Of How PD 0332334 And Metformin Are Eliminated From The Body When They Are Administered At The Same Time

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[email protected]

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Investigation Of How PD 0332334 And Metformin Are Eliminated From The Body When They Are Administered At The Same Time
A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Pharmacokinetics Of PD 0332334 And Metformin When Administered Concurrently In Healthy Subjects
  1. To estimate the effects of multiple doses of PD 0332334 on the elimination of a single dose of metformin from the body
  2. To estimate the effects of multiple doses of metformin on the elimination of a single dose of PD 0332334 from the body
  3. To evaluate the safety and tolerability when PD 0332334 and metformin are administered at the same time.

Detailed Description:

Additional Study Purpose Details: To assess the pharmacokinetics of metformin and PD 0332334 with concurrent administration.

On February 18th 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Generalized Anxiety Disorder
  • Drug: Metformin
    225 mg q12, oral PD 0332334 immediate release formulation on Days 1 through 5; Single, oral, 500 mg dose of metformin immediate release
    Other Name: imagabalin
  • Drug: Metformin
    Single, oral, 500 mg of metformin immediate release
  • Drug: PD 0332334
    500 mg q12, oral metformin immediate release administered on Days 1 through Day 6 Single, oral, 300 mg dose of PD 0332334 immediate release formulation administered on Day 3
  • Drug: PD 0332334
    Single, oral, 300 mg dose of PD 0332334 immediate release formulation
  • Cohort 1
    This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults
    Interventions:
    • Drug: Metformin
    • Drug: Metformin
  • Cohort 2
    This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults
    Interventions:
    • Drug: PD 0332334
    • Drug: PD 0332334
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
February 2009
February 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Nonsmokers
  • Male or female adults

Exclusion Criteria:

  • Current or history of significant medical illness
  • Smokers
  • Illicit drug use
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT00809536
A5361031
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the

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

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