Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00908271

MB102-059

Details and patient eligibility

About

The purpose of this study is to estimate the absolute oral bioavailability of dapagliflozin.

Enrollment: 7 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects (ages 18 to 45) as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study

Exclusion criteria

• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
• Participation in a radiolabeled investigational study drug trial within 12 months prior to admission to the clinical facility
• Exposure to significant radiation within 12 months prior to admission to the clinical facility

Trial design

7 participants in 1 patient group

Dapagliflozin

Other group

Description:

PO and IV

Treatment:

Drug: Dapagliflozin