Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects

Phase 1TerminatedNCT01068756

AstraZeneca14 enrolled

Overview

The purpose of the study is to assess the effects of rifampin on the pharmacokinetics of dapagliflozin

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

DapagliflozinDRUG

Tablets, Oral, 10 mg, 2 single oral 10 mg doses, 2 days

RifampinDRUG

Capsules, Oral, 600 mg, Once daily on days 4 to 11, 8 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subjects * Body Mass Index (BMI) of 18 to 32 inclusive * Women who are not of childbearing potential and men, ages 18 to 45 Exclusion Criteria: * Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG) or clinical laboratory determinations * Glucosuria * Abnormal liver function tests

Locations (1)

Ppd Development

Austin, Texas, United States

Outcomes

Primary Outcomes

AUC (area under the concentration-time curve) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data

Time frame: Days 1 to 3 and Days 9 to 11

Secondary Outcomes

Cmax (maximum observed concentration) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data

Time frame: Days 1 to 3 and Days 9 to 11

Tmax (time of maximum observed concentration) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data

Time frame: Days 1 to 3 and Days 9 to 11

Data from ClinicalTrials.gov

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