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

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Hypertension; Dyslipidemias

Treatments: Drug: CKD-348 F2; Drug: CKD-828, D097, D337; Drug: CKD-348 F1

Study type: Interventional

Funder types: Industry

Identifiers

NCT04258865

A86_05BE1916P

Details and patient eligibility

About

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

Full 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

Enrollment: 30 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adult volunteers aged ≥ 19-year-old
2. Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
3. 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
4. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
6. Those who agree to contraception during the participation of clinical trial
7. 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

1. Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
2. Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug
3. Those who donated whole blood and apheresis within 2 months or received transfusion within 1 month
4. Those who has a history of gastrointestinal surgery (
5. 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
6. Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, shock, dihydropyridine sensitivity, angioedema, cardiac insufficiency
7. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
8. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
9. Women who are pregnant or who may be pregnant and breastfeed

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 6 patient groups

Sequence 1

Experimental group

Description:

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

Treatment:

Drug: CKD-828, D097, D337

Drug: CKD-348 F2

Drug: CKD-348 F1

Sequence 2

Experimental group

Description:

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

Treatment:

Drug: CKD-828, D097, D337

Drug: CKD-348 F2

Drug: CKD-348 F1

Sequence 3

Experimental group

Description:

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

Treatment:

Drug: CKD-828, D097, D337

Drug: CKD-348 F2

Drug: CKD-348 F1

Sequence 4

Experimental group

Description:

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

Treatment:

Drug: CKD-828, D097, D337

Drug: CKD-348 F2

Drug: CKD-348 F1

Sequence 5

Experimental group

Description:

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

Treatment:

Drug: CKD-828, D097, D337

Drug: CKD-348 F2

Drug: CKD-348 F1

Sequence 6

Experimental group

Description:

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

Treatment:

Drug: CKD-828, D097, D337

Drug: CKD-348 F2

Drug: CKD-348 F1