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Study Evaluating Potential Interaction Between SAM-531 And Gemfibrozil When Co-Administered

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NCT00966966

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Utrecht, , 3584 CJ Netherlands
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

- Body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg.

- Healthy as determined by the investigator on the basis of medical history, physical
examination findings, clinical laboratory test results, vital sign measurements, and
digital 12-lead ECG readings.

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

- Presence or history of any disorder that may prevent the successful completion of the
study.

- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI),
endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

NCT00966966
Pfizer
Completed
Study Evaluating Potential Interaction Between SAM-531 And Gemfibrozil When Co-Administered

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[email protected]

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Study Evaluating Potential Interaction Between SAM-531 And Gemfibrozil When Co-Administered
An Open-Label, Nonrandomized Study To Evaluate The Potential Pharmacokinetic Interaction Between SAM-531 and Gemfibrozil, A Cytochrome P-450 2C8 Inhibitor, When Coadministered Orally To Healthy Young Adult Subjects
The purpose of this study is to evaluate the effects of multiple doses of Gemfibrozil on the plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to assess the safety and tolerability of co-administration of SAM-531 and Gemfibrozil.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
Drug: SAM-531 and gemfibrozil
2 single doses of 5 mg SAM-531 (capsules) a daily dose of 1200 mg Gemfibrozil (one tablet of 600mg at approximately 8 a.m. and one tablet of 600 mg at approximately 6 p.m.) for 14 days
Experimental: 1
SAM-531_gemfibrozil
Intervention: Drug: SAM-531 and gemfibrozil
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
December 2009
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg.
  • Healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings.

Exclusion Criteria:

  • Presence or history of any disorder that may prevent the successful completion of the study.
  • Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00966966
3193A1-1109
B1961001
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2010

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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