Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Glimepiride; Drug: Dapagliflozin + Glimepiride; Drug: Dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00562250

MB102-016

Details and patient eligibility

About

The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride

Enrollment: 11 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects with BMI of 18-32 kg/m2

Exclusion criteria

• Abnormal physical or lab findings
• Allergies to any sulfonylurea or related compounds

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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11 participants in 3 patient groups

Arm 1

Experimental group

Treatment:

Drug: Dapagliflozin

Arm 2

Active Comparator group

Treatment:

Drug: Glimepiride

Arm 3

Active Comparator group

Treatment:

Drug: Dapagliflozin + Glimepiride