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

NCT03609606 | Completed Phase 1

• 1 other identifier: 183DDI18011
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dyslipidemias; Hypertension

Keywords

Dyslipidemia; Hypertension; CKD-386; Drug-Drug Interaction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Cmin,ss(Minimum concentration of the drug in plasma at steady state)

  0(predose)~24 hours at Day7 and Day28

• Tmax,ss(Time to maximum plasma concentration at steady state)

  0(predose)~24 hours at Day7 and Day28

• t1/2(Terminal elimination half-life)

  0(predose)~24 hours at Day7 and Day28

• CLss/F(Apparent total body clearance of the drug from plasma at steady state)

  0(predose)~24 hours at Day7 and Day28

• Vd,ss/F(Apparent volume of distribution at steady state)

  0(predose)~24 hours at Day7 and Day28

Study Arms (4)

Part A, Sequence1

EXPERIMENTAL

* Period 1: Treatment of D013, D326 and D337 on Day1\~Day7 * Period 2: Treatment of D013 on Day22\~Day28

Drug: D013, D326 and D337; Drug: D013

Part A, Sequence 2

EXPERIMENTAL

* Period 1: Treatment of D013 on Day1\~Day7 * Period 2: Treatment of D013, D326 and D337 on Day22\~Day28

Drug: D013, D326 and D337; Drug: D013

Part B, Sequence 1

EXPERIMENTAL

* 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; Drug: D326 and D337

Part B, Sequence 2

EXPERIMENTAL

* 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; Drug: D326 and D337

Interventions

D013, D326 and D337 DRUG

Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days

Also known as: CKD-386 Test

Part A, Sequence 2; Part A, Sequence1; Part B, Sequence 1; Part B, Sequence 2

D013 DRUG

Daily oral administration of 1 tablet under fasting conditions for 7 days

Also known as: CKD-386 Reference1

Part A, Sequence 2; Part A, Sequence1

D326 and D337 DRUG

Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days

Also known as: CKD-386 Reference2

Part B, Sequence 1; Part B, Sequence 2

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers aged between ≥ 20 and ≤ 45 years old
• Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²
• 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
• Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study

You may not qualify if:

• History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder
• With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration
• Any medical history that may affect drug absorption, distribution, metabolism and excretion
• Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
• Any clinically significant active chronic disease

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias; Hypertension

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ji-Young Park, M.D., Ph.D

  Department of Pharmacology, College of Medicine/ Department of Clinical Pharmacology&Toxicology, Anam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 1, 2018
• Study Start: August 9, 2018
• Primary Completion: September 14, 2018
• Study Completion: September 27, 2018
• Last Updated: October 5, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)