Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With DWC202001 and DWC202002 in Healthy Male Adults

NCT ID: NCT04343547

Last Updated: 2020-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-30
• Study Completion Date: 2020-07-31

Brief Summary

The purpose of this study is to evaluate drug-drug interaction by comparing the pharmacokinetics (PK)/pharmacodynamics (PD), safety, and tolerability of single/multiple doses of DWP16001 , DWC202001 and DWC202002 alone or in combination in healthy male adults.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

DWP16001

Intervention Type: DRUG

Tablets, Oral, once daily single dose

2

Group Type: EXPERIMENTAL

DWC202001+DWC202002

Intervention Type: DRUG

Tablets, Oral, multiple doses of DWC202001 and DWC202002 in combination

Experimental 3

Group Type: EXPERIMENTAL

DWP16001+DWC202001+DWC202002

Intervention Type: DRUG

Tablets, Oral, DWP16001 , DWC202001 and DWC202002 in combination

Interventions

DWP16001

Tablets, Oral, once daily single dose

Intervention Type: DRUG

DWC202001+DWC202002

Tablets, Oral, multiple doses of DWC202001 and DWC202002 in combination

Intervention Type: DRUG

DWP16001+DWC202001+DWC202002

Tablets, Oral, DWP16001 , DWC202001 and DWC202002 in combination

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy male adults ≥ 19 and ≤ 50 years of age at the time of the screening procedure

2. 55.0 kg ≤ body weight ≤ 90.0 kg and 18.0 ≤ body mass index (BMI) ≤ 27.0

3. Voluntarily decided to participate in the study and provided written consent prior to the screening procedure after receiving a detailed explanation on this study and fully understanding the information

4. Is eligible to participate in the study at the discretion of the investigator by a physical examination, laboratory test, and medical history questionnaire, etc.

Exclusion Criteria

1. Presence or prior history of a clinically significant hepatic, renal, nervous, respiratory, endocrine, hematologic and oncologic, cardiovascular, urogenital, psychiatric disorder

2. Presence or prior history of a gastrointestinal disorder (e.g., gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.), or prior history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the safety and PK/PD assessment of the study drug.

3. Hypersensitivity to, or history of clinically significant hypersensitivity to drugs including DWP16001 and other drugs of the same class (SGLT2 inhibitors), drugs including gemigliptin and other drugs of the same class, metformin and other drugs (aspirin, antibiotics, etc.)

4. Considered ineligible for the study by the investigator for reasons including laboratory test results

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Central Contacts

Jin Hyun Choi

Role: CONTACT

jhchoi413@daewoong.co.kr

82-02-550-8406

Other Identifiers

DW_DWP16001104

Identifier Type: -

Identifier Source: org_study_id