Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults (Phase 1 Study)

• Status: Completed
• Trial end date: 2019-11-20
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate drug-drug interaction of DWP16001 in combination with metformin IR 1000mg in Healthy male subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Healthy male adults aged 19 to 50 years at the time of screening test

• 55.0 kg ≤ Body weight ≤ 90.0 kg and 18.0 ≤ Body Mass Index (BMI) ≤ 27.0

• Written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study

• Eligible to participate in the study at the discretion of the investigator by physical examination, laboratory test, and history taking, etc.

Exclusion Criteria:

• Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder

• Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug

• Hypersensitivity or medical history of clinically significant hypersensitivity to a drug containing an ingredient of the investigational product (DWP16001), Dapagliflozin, Metformin or similar ingredient or other drugs (e.g., aspirin, antibiotics, etc.)

• Clinical laboratory test values are outside the accepted normal range at screening

• Other exclusive inclusion criteria, as defined in the protocol