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

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: DWC202001+DWC202002; Drug: DWP16001+DWC202001+DWC202002; Drug: DWP16001

Study type: Interventional

Funder types: Industry

Identifiers

NCT04343547

DW_DWP16001104

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: DWP16001

2

Experimental group

Treatment:

Drug: DWC202001+DWC202002

Experimental 3

Experimental group

Treatment:

Drug: DWP16001+DWC202001+DWC202002