A Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects

Hypertension Clinical Trial

Official title:

An Open-label, Randomized, Multiple-dose Crossover Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03609606
• Other study ID #: 183DDI18011
• Status: Completed
• Phase: Phase 1
• Start date: August 9, 2018
• Est. completion date: September 27, 2018

Study information

• Verified date: October 2018
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study to investigate drug interaction between D326, D337, and D013 in healthy male subjects

Description:

An open-label, randomized, multiple-dose crossover study to investigate drug interaction between D326, D337, and D013 in healthy male subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: September 27, 2018
• Est. primary completion date: September 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Healthy volunteers aged between = 20 and = 45 years old

2. Weight = 50kg, with calculated body mass index(BMI) of = 18 and = 29.9kg/m²

3. Subjects who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods for up to 28 days after the date of administration of the clinical trial drug and agree not to provide sperm

4. Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study

Exclusion Criteria:

1. History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder

2. With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration

3. Any medical history that may affect drug absorption, distribution, metabolism and excretion

4. Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder

5. Any clinically significant active chronic disease

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension

Intervention

Drug:
• D013, D326 and D337
Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days
• D013
Daily oral administration of 1 tablet under fasting conditions for 7 days
• D326 and D337
Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)	Part A: Pharmacokinetic parameter of D013 after multiple dosing; Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing	0(predose)~24 hours at Day7 and Day28
Primary	Cmax,ss(Maximum plasma concentration of the drug at steady state)	Part A: Pharmacokinetic parameter of D013 after multiple dosing; Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing	0(predose)~24 hours at Day7 and Day28
Secondary	Cmin,ss(Minimum concentration of the drug in plasma at steady state)	Part A: Pharmacokinetic parameter of D013 after multiple dosing; Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing	0(predose)~24 hours at Day7 and Day28
Secondary	Tmax,ss(Time to maximum plasma concentration at steady state)	Part A: Pharmacokinetic parameter of D013 after multiple dosing; Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing	0(predose)~24 hours at Day7 and Day28
Secondary	t1/2(Terminal elimination half-life)	Part A: Pharmacokinetic parameter of D013 after multiple dosing; Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing	0(predose)~24 hours at Day7 and Day28
Secondary	CLss/F(Apparent total body clearance of the drug from plasma at steady state)	Part A: Pharmacokinetic parameter of D013 after multiple dosing; Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing	0(predose)~24 hours at Day7 and Day28
Secondary	Vd,ss/F(Apparent volume of distribution at steady state)	Part A: Pharmacokinetic parameter of D013 after multiple dosing; Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing	0(predose)~24 hours at Day7 and Day28
Secondary	PTF(Peak-to-trough fluctuation)	Part A: Pharmacokinetic parameter of D013 after multiple dosing; Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing	0(predose)~24 hours at Day7 and Day28