Status unknownNCT03726866Updated Nov 1, 2018

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

A Phase 1 interventional study of Sequence 1 and Sequence 2 in Dyslipidemias and Hypertension, sponsored by Chong Kun Dang Pharmaceutical. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-01.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 19 Years to 40 Years
Sex: All

Study 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.

Conditions studied

Dyslipidemias
Hypertension

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Keywords

dyslipidemias
hypertension
Drug-Drug interaction

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 30 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 40 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy volunteers aged between ≥ 19 and ≤ 40 years old
Calculated body mass index(BMI) of ≥ 19 and ≤ 28kg/m²
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
Subject who agree not to provide sperm
Subject who voluntarily agree to participate in this study

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 30 participants (estimated)

Study arms

Experimental
Sequence 1
Sequence 1
Drug: Sequence 1
Experimental
Sequence 2
Sequence 2
Drug: Sequence 2
Experimental
Sequence 3
Sequence 3
Drug: Sequence 3
Experimental
Sequence 4
Sequence 4
Drug: Sequence 4
Experimental
Sequence 5
Sequence 5
Drug: Sequence 5
Experimental
Sequence 6
Sequence 6
Drug: Sequence 6

Interventions

DrugSequence 1
D326, D337 or CKD-828 for 9 days
DrugSequence 2
D326, D337 or CKD-828 for 9 days
DrugSequence 3
D326, D337 or CKD-828 for 9 days
DrugSequence 4
D326, D337 or CKD-828 for 9 days
DrugSequence 5
D326, D337 or CKD-828 for 9 days
DrugSequence 6
D326, D337 or CKD-828 for 9 days

What researchers measure

Primary outcomes

Cmax(Maximum plasma concentration of the drug at steady state)
PK parameters of D326, D337 and CKD-828
Time frame: 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
Time frame: at Day 9

Secondary outcomes

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

Study locations

1 of 1 sites recruiting

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03726866
Lead sponsor: Chong Kun Dang Pharmaceutical
Responsible party: Sponsor
First posted: Nov 1, 2018
Start date: Aug 31, 2018
Primary completion: Jan 15, 2019 (estimated)
Completion: Jan 15, 2019 (estimated)
Last update: Nov 1, 2018

Study contacts

Jihwan Oh

Contact

jihwan@ckdpharm.com

82-2-6373-0953

Hyeong-Seok Lim, M.D., Ph.D.

principal investigator · Department of Clinical Pharmacology and Therapeutics / Asan Medical Center, University of Ulsan

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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