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

NCT04064073 | Completed Phase 1

• 1 other identifier: DW_DWP16001102
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Cmax of DWP16001

  Peak Plasma Concetration

  0-72 hours

• AUClast of DWP16001

  Area under the plasma concentration versus time curve

  0-72 hours

• Cmax,ss of Metformin

  Peak Plasma Concetration at steady-state

  0-144 hours

• AUCτ,ss of Metformin

  Area under the plasma concentration versus time curve at Tau, steady-state

  0-144 hours

Secondary Outcomes (6)

• Tmax of DWP 16001, Metformin, DWP16001 Metabolites

  0-144 hours

• AUC of DWP 16001, Metformin, DWP16001 Metabolites

  0-144 hours

• T1/2 of DWP 16001, Metformin

  0-144 hours

• CL/F of DWP 16001, Metformin

  0-144 hours

• fe of DWP 16001, DWP16001 Metabolites

  0-72 hours

Study Arms (3)

1

EXPERIMENTAL

Drug: DWP16001

2

EXPERIMENTAL

Drug: Metformin IR

3

EXPERIMENTAL

Drug: DWP16001+Metformin IR

Interventions

DWP16001 DRUG

Tablets, Oral, once daily single dose

1

Metformin IR DRUG

Metformin IR 1000mg, Tablets, Oral, BID for 7 days

2

DWP16001+Metformin IR DRUG

Tablets, Oral, once daily single dose DWP16001 Metformin IR 1000mg

3

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Enavogliflozin

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 21, 2019
• Study Start: August 14, 2019
• Primary Completion: November 20, 2019
• Study Completion: November 20, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

KR (1)