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

Phase 1

• Conditions: Dyslipidemias; Hypertension
• Interventions: Drug: Sequence 1; Drug: Sequence 2; Drug: Sequence 3; Drug: Sequence 4; Drug: Sequence 5; Drug: Sequence 6

• Registration Number: NCT03726866
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-31
• Status Verified: 2018-10
• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-10-30
• Last Update Submitted: 2018-10-30
• Study First Posted: 2018-11-01
• Last Update Posted: 2018-11-01
• Primary Completion: 2019-01-15
• Study Completion: 2019-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	Sequence 1	Sequence 1
Sequence 2	Sequence 2	Sequence 2
Sequence 3	Sequence 3	Sequence 3
Sequence 4	Sequence 4	Sequence 4
Sequence 5	Sequence 5	Sequence 5
Sequence 6	Sequence 6	Sequence 6

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center, University of Ulsan; 🇰🇷 Seoul, Korea, Republic of