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

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension; Dyslipidemias
• Intervention / Treatment: Drug: D013, D326 and D337; Drug: D013; Drug: D326 and D337

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A, Sequence1; Period 1: Treatment of D013, D326 and D337 on Day1~Day7; Period 2: Treatment of D013 on Day22~Day28	Drug: D013, D326 and D337; Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days; Other Names: CKD-386 Test; Drug: D013; Daily oral administration of 1 tablet under fasting conditions for 7 days; Other Names: CKD-386 Reference1
Experimental: Part A, Sequence 2; Period 1: Treatment of D013 on Day1~Day7; Period 2: Treatment of D013, D326 and D337 on Day22~Day28	Drug: D013, D326 and D337; Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days; Other Names: CKD-386 Test; Drug: D013; Daily oral administration of 1 tablet under fasting conditions for 7 days; Other Names: CKD-386 Reference1
Experimental: Part B, Sequence 1; Period 1: Treatment of D013, D326 and D337 on Day1~Day7; Period 2: Treatment of D326 and D337 on Day22~Day28	Drug: D013, D326 and D337; Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days; Other Names: CKD-386 Test; Drug: D326 and D337; Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days; Other Names: CKD-386 Reference2
Experimental: Part B, Sequence 2; Period 1: Treatment of D326 and D337 on Day1~Day7; Period 2: Treatment of D013, D326 and D337 on Day22~Day28	Drug: D013, D326 and D337; Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days; Other Names: CKD-386 Test; Drug: D326 and D337; Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days; Other Names: CKD-386 Reference2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Ji-Young Park, M.D., Ph.D, Department of Pharmacology, College of Medicine/ Department of Clinical Pharmacology&Toxicology, Anam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2018
• Primary Completion (Actual): September 14, 2018
• Study Completion (Actual): September 27, 2018

Study Registration Dates

• First Submitted: July 25, 2018
• First Submitted That Met QC Criteria: July 25, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): October 5, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Dyslipidemia; Hypertension; CKD-386; Drug-Drug Interaction
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Hypertension; Dyslipidemias
• Other Study ID Numbers: 183DDI18011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No