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To Explore The Potential For PF-04531083 To Effect The Blood Concentrations Of Simvastatin And Its Main Acid Metabolite Following Co-Administration Of Both Medications

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NCT01103739

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , 1070 Belgium
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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.
Chronic Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- young

- healthy

- male and female volunteers

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

- Elderly

- Patients

NCT01103739
Pfizer
Completed
To Explore The Potential For PF-04531083 To Effect The Blood Concentrations Of Simvastatin And Its Main Acid Metabolite Following Co-Administration Of Both Medications

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To Explore The Potential For PF-04531083 To Effect The Blood Concentrations Of Simvastatin And Its Main Acid Metabolite Following Co-Administration Of Both Medications
A Phase 1, Open Label, Fixed Sequence Study To Investigate The Effect Of Multiple Doses Of PF-04531083 On Simvastatin And Simvastatin Acid Pharmacokinetics Following Single Dose Of Simvastatin in Healthy Volunteers
The purpose of this study is to quantify the effect of multiple doses of PF-04531083 on the pharmacokinetics (PK) of co-administered single dose simvastatin.
observational- quantify any effects of PF_04531083 on the PK of Simvastatin
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Chronic Pain
  • Drug: PF-04531083
    PF-04531083: 100mg to be dosed twice daily as a suspension from Day 2 through Day 14 of the study.
  • Drug: simvastatin
    Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study.
  • Drug: PF-04531083
    PF-04531083: a dose to be selected depending on results from Cohort 1 to be dosed twice daily as a suspension from Day 2 through Day 14 of the study.
  • Experimental: cohort 1
    Interventions:
    • Drug: PF-04531083
    • Drug: simvastatin
  • Experimental: cohort 2
    Interventions:
    • Drug: PF-04531083
    • Drug: simvastatin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
May 2010
May 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • young
  • healthy
  • male and female volunteers

Exclusion Criteria:

  • Elderly
  • Patients
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01103739
B1351007
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2010

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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