Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01068756

Enrollment

Registered

2010-02-15

Start date

2010-03-31

Completion date

2010-04-30

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

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

Interventions

DRUGDapagliflozin

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

DRUGRifampin

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUC (area under the concentration-time curve) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data	Days 1 to 3 and Days 9 to 11

Secondary

Measure	Time frame
Cmax (maximum observed concentration) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data	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	Days 1 to 3 and Days 9 to 11

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026