CompletedNCT04258865CKD-348Updated Jun 5, 2020

A Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348

A Phase 1 interventional study of CKD-348 F1 and CKD-348 F2 in Hypertension and Dyslipidemias, sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-05.

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

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 19 Years to 65 Years
Sex: All

Study summary

A clinical trial to compare the pharmacokinetics and tolerability of CKD-348

Read the detailed description

A randomized, open-label, single-dose, 3-way crossover clinical trial to compare the pharmacokinetics and tolerability of CKD-348 with co-administrated drugs in healthy adult volunteers

Conditions studied

Hypertension
Dyslipidemias

Browse trials for

Dyslipidemias 1,073

Keywords

CKD-348

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's enrollment of 30 is below the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias 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 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy adult volunteers aged ≥ 19-year-old
Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
Those who are eligible for adequate blood pressure criteria during screening tests Systolic blood pressure: 90 to 139 mmHg Diastolic blood pressure: 60 to 89 mmHg
Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
Those who agree to contraception during the participation of clinical trial
Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

Exclusion criteria

Exclusion Criteria:

Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug
Those who donated whole blood and apheresis within 2 months or received transfusion within 1 month
Those who has a history of gastrointestinal surgery (
Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30mL) Smoke: 20 cigarettes/day
Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, shock, dihydropyridine sensitivity, angioedema, cardiac insufficiency
Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
Women who are pregnant or who may be pregnant and breastfeed

Study design

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

Study arms

Experimental
Sequence 1
Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
Drug: CKD-348 F1 · Drug: CKD-348 F2 · Drug: CKD-828, D097, D337
Experimental
Sequence 2
Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
Drug: CKD-348 F1 · Drug: CKD-348 F2 · Drug: CKD-828, D097, D337
Experimental
Sequence 3
Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
Drug: CKD-348 F1 · Drug: CKD-348 F2 · Drug: CKD-828, D097, D337
Experimental
Sequence 4
Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Drug: CKD-348 F1 · Drug: CKD-348 F2 · Drug: CKD-828, D097, D337
Experimental
Sequence 5
Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
Drug: CKD-348 F1 · Drug: CKD-348 F2 · Drug: CKD-828, D097, D337
Experimental
Sequence 6
Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Drug: CKD-348 F1 · Drug: CKD-348 F2 · Drug: CKD-828, D097, D337

Interventions

DrugCKD-348 F1
QD, PO
DrugCKD-348 F2
QD, PO
DrugCKD-828, D097, D337
QD, PO

What researchers measure

Primary outcomes

AUCt of CKD-348
AUCt: Area under the concentration-time curve from time zero to time
Time frame: Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Cmax of CKD-348
Cmax: Maximum plasma concentration of the drug
Time frame: Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

Secondary outcomes

AUCinf of CKD-348
AUCinf: Area under the concentration-time curve from zero up to ∞
Time frame: Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Tmax of CKD-348
Tmax: Time to maximum plasma concentration
Time frame: Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
t1/2 of CKD-348
t1/2: Terminal elimination half-life
Time frame: Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
AUCt/AUCinf of CKD-348
AUCt/AUCinf
Time frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

Study locations

1 site

H Plus Yangji Hospital
Seoul, Gwanak-gu 08779, Korea, Republic of

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04258865
Lead sponsor: Chong Kun Dang Pharmaceutical
Responsible party: Sponsor
First posted: Feb 6, 2020
Start date: Mar 25, 2020
Primary completion: Apr 26, 2020
Completion: May 13, 2020
Last update: Jun 5, 2020

Study contacts

Yook-Hwan Noh, M.D., PhD.

principal investigator · H Plus Yangji Hospital

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 completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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