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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 Infinity

Sitagliptin 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 Infinity

Sitagliptin + 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

Page last updated: August 23, 2015

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