A Study to Investigate Drug-Drug Interaction Between D326, D337 and CKD-828 in Healthy Subjects

A Randomized, Open Label, Repeated-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interactions and Safety Among D326, D337 and CKD-828 in Healthy Subjects

To evaluate pharmacokinetic properties and drug interactions between D326 and D337 co-administered groups, the CKD-828 alone and the total co-administered groups.

Study Overview

• Status: Unknown
• Conditions: Hypertension; Dyslipidemias
• Intervention / Treatment: Drug: Sequence 1; Drug: Sequence 2; Drug: Sequence 3; Drug: Sequence 4; Drug: Sequence 5; Drug: Sequence 6

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jihwan Oh; Phone Number: 82-2-6373-0953; Email: jihwan@ckdpharm.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Asan Medical Center, University of Ulsan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy volunteers aged between ≥ 19 and ≤ 40 years old
2. Calculated body mass index(BMI) of ≥ 19 and ≤ 28kg/m²
3. Subject who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods from the date of first administration of Investigational product until completion of the clinical trial
4. Subject who agree not to provide sperm
5. Subject who voluntarily agree to participate in this study

Exclusion Criteria:

1. Any medical history that may affect drug absorption, distribution, metabolism and excretion
2. Subject who has a clinically significant disease or history such as endocrine, gastrointestinal, cardiovascular, muscular disease.
3. Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
4. Subject who have received other clinical trial drugs within 90 days prior to the screening visit
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

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1	Drug: Sequence 1; D326, D337 or CKD-828 for 9 days
Experimental: Sequence 2	Drug: Sequence 2; D326, D337 or CKD-828 for 9 days
Experimental: Sequence 3	Drug: Sequence 3; D326, D337 or CKD-828 for 9 days
Experimental: Sequence 4	Drug: Sequence 4; D326, D337 or CKD-828 for 9 days
Experimental: Sequence 5	Drug: Sequence 5; D326, D337 or CKD-828 for 9 days
Experimental: Sequence 6	Drug: Sequence 6; D326, D337 or CKD-828 for 9 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax(Maximum plasma concentration of the drug at steady state)	PK parameters of D326, D337 and CKD-828	at Day 9
AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)	PK parameters of D326, D337 and CKD-828	at Day 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax(Time to maximum plasma concentration at steady state)	PK parameters of D326, D337 and CKD-828	at Day 9
t1/2(Terminal elimination half-life)	PK parameters of D326, D337 and CKD-828	at Day 9

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Hyeong-Seok Lim, M.D., Ph.D., Department of Clinical Pharmacology and Therapeutics / Asan Medical Center, University of Ulsan

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2018
• Primary Completion (Anticipated): January 15, 2019
• Study Completion (Anticipated): January 15, 2019

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): November 1, 2018
• Last Update Submitted That Met QC Criteria: October 30, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: hypertension; dyslipidemias; Drug-Drug interaction
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Hypertension; Dyslipidemias
• Other Study ID Numbers: 186DDI18020

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