The Role of P-glycoprotein in Sitagliptin Clinical Pharmacology
Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Sitagliptin (Drug); atorvastatin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Colorado, Denver Official(s) and/or principal investigator(s): Christina L Aquilante, PharmD, Principal Investigator, Affiliation: University of Colorado, Denver
Summary
The purpose of this study is to determine the pharmacogenetics, pharmacokinetics, and
drug-drug interactions of sitagliptin therapy.
Clinical Details
Official title: The Role of P-glycoprotein in Sitagliptin Clinical Pharmacology
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Sitagliptin Monotherapy: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to InfinitySitagliptin Monotherapy: Sitagliptin Maximum Plasma Concentration (Cmax) Sitagliptin Monotherapy: Sitagliptin Renal Clearance (CLr)
Secondary outcome: Sitagliptin + Atorvastatin: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to InfinitySitagliptin + Atorvastatin: Sitagliptin Maximum Plasma Concentration (Cmax) Sitagliptin + Atorvastatin: Sitagliptin Renal Clearance (CLr)
Eligibility
Minimum age: 21 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy men and women between 21 to 60 years of age will be recruited to participate
in this study.
- Subjects will be eligible if metabolic, renal, hepatic, and hematological laboratory
tests are within normal limits.
Exclusion Criteria:
- Subjects will be excluded from the study if they have a current or past history of
cardiovascular, hepatic, endocrine (e. g., diabetes), renal, pancreatic,
gastrointestinal, pulmonary, immunologic, hematologic, or neurologic disease.
Locations and Contacts
University of Colorado Denver, Aurora, Colorado 80045, United States
Additional Information
Starting date: November 2009
Last updated: January 22, 2013
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