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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: DWP16001; Drug: DWP16001+Metformin IR; Drug: Metformin IR

• Registration Number: NCT04064073
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-02
• Study Start: 2019-08-14
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-21
• Primary Completion: 2019-11-20
• Study Completion: 2019-11-20
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-08
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	DWP16001	-
3	DWP16001+Metformin IR	-
2	Metformin IR	-

Primary Outcome Measures

Name	Time	Method
Cmax of DWP16001	0-72 hours	Peak Plasma Concetration
Cmax,ss of Metformin	0-144 hours	Peak Plasma Concetration at steady-state
AUClast of DWP16001	0-72 hours	Area under the plasma concentration versus time curve
AUCτ,ss of Metformin	0-144 hours	Area under the plasma concentration versus time curve at Tau, steady-state

Secondary Outcome Measures

Name	Time	Method
Tmax of DWP 16001, Metformin, DWP16001 Metabolites	0-144 hours	Time at Cmax
T1/2 of DWP 16001, Metformin	0-144 hours
fe of DWP 16001, DWP16001 Metabolites	0-72 hours	Fraction of the drug excreted into the urine
AUC of DWP 16001, Metformin, DWP16001 Metabolites	0-144 hours	Area under the plasma concentration versus time curve
CL/F of DWP 16001, Metformin	0-144 hours	Apparent total clearance of the drug from plasma after oral administration
CLR of DWP 16001	0-144 hours	Renal clearance of the drug from plasma

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of