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

Healthy Clinical Trial

Official title:

A Randomized, Open Label, Single/Multiple Dose, Crossover Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With DWC202001 and DWC202002 in Healthy Male Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04343547
• Other study ID #: DW_DWP16001104
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 2020
• Est. completion date: July 2020

Study information

• Verified date: April 2020
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: Jin Hyun Choi
• Phone: 82-02-550-8406
• Email: jhchoi413[@]daewoong.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• DWP16001
Tablets, Oral, once daily single dose
• DWC202001+DWC202002
Tablets, Oral, multiple doses of DWC202001 and DWC202002 in combination
• DWP16001+DWC202001+DWC202002
Tablets, Oral, DWP16001 , DWC202001 and DWC202002 in combination

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of DWP16001	Peak Plasma Concetration	0-72 hours
Primary	AUClast of DWP16001	Area under the plasma concentration versus time curve	0-72 hours
Primary	Cmax,ss of DWC202001 and DWC202002	Peak Plasma Concetration at steady-state	0-72 hours
Primary	AUCt,ss of DWC202001 and DWC202002	Area under the plasma concentration versus time curve at Tau, steady-state	0-72 hours
Secondary	Tmax of DWP 16001, DWC202001 and DWC202002	Time at Cmax	0-72 hours
Secondary	T1/2 of DWP 16001, DWC202001 and DWC202002		0-72 hours
Secondary	CL/F of DWC202001 and DWC202002		0-72 hours