drugset / Trial / NCT01135446

Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects

NCT01135446

Phase 1 Completed 35 enrolled AstraZeneca Bristol-Myers Squibb · collab
RandomizedParallel-groupOpen-label

Summary

The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single oral doses of 0.001 mg to 2.5 mg dapagliflozin in healthy subjects.

Timeline

Start
2010-05
Primary completion
2010-06
Completion
2010-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Dapagliflozin Small molecule 0.001 mg Oral
Subject Dapagliflozin Small molecule 0.01 mg Oral
Subject Dapagliflozin Small molecule 0.1 mg Oral
Subject Dapagliflozin Small molecule 0.3 mg Oral
Subject Dapagliflozin Small molecule 1 mg Oral
Subject Dapagliflozin Small molecule 2.5 mg Oral