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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
35
Oral Solution, Oral, 0.001 mg, once on Day 1 only, 2 days
Oral Solution, Oral, 0.01 mg, once on Day 1 only, 2 days
Oral Solution, Oral, 0.1 mg, once on Day 1 only, 2 days
Ppd Development, Lp
Austin, Texas, United States
Total 24-hour Urinary Glucose Excretion as a Measure of Pharmacodynamic Effect
Time frame: 24 hours after dosing
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 24 hours after dosing
Dapagliflozin and Dapagliflozin 3-O-glucuronide (Metabolite of Dapagliflozin) Concentrations to Characterize Dapagliflozin Pharmacokinetics
Time frame: 2 days after dosing
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Tablets, Oral, 0.3 mg, once on Day 1 only, 2 days
Tablets, Oral, 1 mg, once on Day 1 only, 2 days
Tablets, Oral, 2.5 mg, once on Day 1 only, 2 days