A Study Of PF-03882845 Absorption In Healthy Volunteers Given Orally As Tablet Versus Suspension Formulations And Effect Of Food On Its Absorption
NCT01366287
Last updated date
ABOUT THIS STUDY
The primary purpose of this study is to estimate the relative bioavailability and food effect
of a PF-03882845 tablet as compared to a suspension formulation used in previous clinical
studies.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ 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 and/or female subjects between the ages of 18 and 55 years,Females must be of non-childbearing potential. Body mass index of 17.5 to 30.5 kg/m2.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Serum potassium >5 mEq/L at screening.
- Impaired kidney function (estimated GFR <60 mL/min/1.73 m2). History of sensitivity to
eplerenone, spironolactone, or related compounds.
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Study Of PF-03882845 Absorption In Healthy Volunteers Given Orally As Tablet Versus Suspension Formulations And Effect Of Food On Its Absorption | |||
| Official Title ICMJE | A Randomized, Open-Label, Single Dose, Crossover Study To Estimate The Relative Oral Bioavailability And Food Effect Of PF-03882845 In Healthy Adult Volunteers | |||
| Brief Summary | The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-03882845 tablet as compared to a suspension formulation used in previous clinical studies. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Basic Science | |||
| Condition ICMJE | Diabetes Mellitus, Type 2 | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| Publications * | Not Provided | |||
* 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 | 12 | |||
| Original Actual Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | February 2011 | |||
| Actual Primary Completion Date | February 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 | Belgium | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01366287 | |||
| Other Study ID Numbers ICMJE | B0171006 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | June 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||