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

Phase 1

Completed

• Conditions: Hypertension; Dyslipidemias
• Interventions: Drug: D013, D326 and D337; Drug: D013; Drug: D326 and D337

• Registration Number: NCT03609606
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2018-07-25
• Study First Submitted QC: 2018-07-25
• Study First Posted: 2018-08-01
• Study Start: 2018-08-09
• Primary Completion: 2018-09-14
• Study Completion: 2018-09-27
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-04
• Last Update Posted: 2018-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 69

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part A, Sequence1	D013	* Period 1: Treatment of D013, D326 and D337 on Day1\~Day7 * Period 2: Treatment of D013 on Day22\~Day28
Part B, Sequence 1	D013, D326 and D337	* Period 1: Treatment of D013, D326 and D337 on Day1\~Day7 * Period 2: Treatment of D326 and D337 on Day22\~Day28
Part B, Sequence 2	D013, D326 and D337	* Period 1: Treatment of D326 and D337 on Day1\~Day7 * Period 2: Treatment of D013, D326 and D337 on Day22\~Day28
Part A, Sequence1	D013, D326 and D337	* Period 1: Treatment of D013, D326 and D337 on Day1\~Day7 * Period 2: Treatment of D013 on Day22\~Day28
Part B, Sequence 1	D326 and D337	* Period 1: Treatment of D013, D326 and D337 on Day1\~Day7 * Period 2: Treatment of D326 and D337 on Day22\~Day28
Part B, Sequence 2	D326 and D337	* Period 1: Treatment of D326 and D337 on Day1\~Day7 * Period 2: Treatment of D013, D326 and D337 on Day22\~Day28
Part A, Sequence 2	D013, D326 and D337	* Period 1: Treatment of D013 on Day1\~Day7 * Period 2: Treatment of D013, D326 and D337 on Day22\~Day28
Part A, Sequence 2	D013	* Period 1: Treatment of D013 on Day1\~Day7 * Period 2: Treatment of D013, D326 and D337 on Day22\~Day28

Primary Outcome Measures

Name	Time	Method
AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)	0(predose)~24 hours at Day7 and Day28	* Part A: Pharmacokinetic parameter of D013 after multiple dosing; * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Cmax,ss(Maximum plasma concentration of the drug at steady state)	0(predose)~24 hours at Day7 and Day28	* Part A: Pharmacokinetic parameter of D013 after multiple dosing; * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

Secondary Outcome Measures

Name	Time	Method
PTF(Peak-to-trough fluctuation)	0(predose)~24 hours at Day7 and Day28	* Part A: Pharmacokinetic parameter of D013 after multiple dosing; * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Vd,ss/F(Apparent volume of distribution at steady state)	0(predose)~24 hours at Day7 and Day28	* Part A: Pharmacokinetic parameter of D013 after multiple dosing; * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Tmax,ss(Time to maximum plasma concentration at steady state)	0(predose)~24 hours at Day7 and Day28	* Part A: Pharmacokinetic parameter of D013 after multiple dosing; * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
t1/2(Terminal elimination half-life)	0(predose)~24 hours at Day7 and Day28	* Part A: Pharmacokinetic parameter of D013 after multiple dosing; * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
Cmin,ss(Minimum concentration of the drug in plasma at steady state)	0(predose)~24 hours at Day7 and Day28	* Part A: Pharmacokinetic parameter of D013 after multiple dosing; * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing
CLss/F(Apparent total body clearance of the drug from plasma at steady state)	0(predose)~24 hours at Day7 and Day28	* Part A: Pharmacokinetic parameter of D013 after multiple dosing; * Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of