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

Daewoong Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: DWP16001+Metformin IR

Drug: DWP16001

Drug: Metformin IR

Study type

Interventional

Funder types

Industry

Identifiers

DW_DWP16001102

Details and patient eligibility

About

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

Enrollment

34 patients

Sex

Male

Ages

19 to 50 years old

Volunteers

Accepts Healthy Volunteers

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