A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(5) 80/20/10mg

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Hypertension and Dyslipidemia

Treatments: Drug: CKD-386(5); Drug: D013, D326, D337

Study type: Interventional

Funder types: Industry

Identifiers

NCT05698043

A83_10BE2223

Details and patient eligibility

About

A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-386(5)

Full description

An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to evaluate the pharmacokinetics and the tolerability of CKD-386(5) with co-administration of D013, D326, and D337 in healthy adult volunteers

Enrollment: 63 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adult volunteers aged ≥ 19 years

2. Weight ≥55kg with calculated body mass index (BMI) of 18 to 30 kg/m2

3. Those who meet the 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 diseases or chronic diseases and have no abnormal symptoms or findings.

5. Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.

6. Those who agree to contraception during the participation of clinical trial.

7. Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion criteria

1. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.

2. Those who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing date, or who have used drugs that may interfere with this study within 10 days before the first dosing day (However, clinical investigational drugs) Participation is possible in consideration of pharmacokinetic and pharmacodynamic characteristics such as interaction with concomitant drugs and half-life of concomitant drugs)

3. Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a 4 weeks.

4. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.

5. Those who exceed an alcohol and cigarette consumption than below criteria

   • Alcohol: Man_21 glasses/week, Woman_14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)
   • Heavy Smoking: 20 cigarettes/day

6. Patients with the following diseases

   • Patients with hypersensitivity to the main constituents or components of the investigational drug
   • Severe hepatic impairment, biliary atresia or cholestasis
   • Patients with hereditary angioedema or with a history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor antagonists
   • Diabetes mellitus
   • Patients with moderate to severe renal impairment [glomerular filtration rate (eGFR) <60 mL / min / 1.73m^2]
   • Renal vascular hypertension patients
   • Patients with active liver disease, including unexplained persistent serum transaminase elevations or elevated serum transaminase elevations greater than three times the normal upper limit
   • Patients with myopathy or have a history of family or genetic history of myopathy
   • Hypothyroidism
   • If you have a history of muscle toxicity for other HMG-CoA converting enzymes or fibrate class drugs

7. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.

8. Those who are deemed insufficient to participate in this clinical study by investigators.

9. Woman who are pregnant or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

Sequence 1

Experimental group

Description:

* Period 1: D013, D326, D337- A single oral dose of 3 tablets under fasting condition * Period 2: CKD-386(5)- A single oral dose of 1 tablet under fasting condition * Period 3: D013, D326, D337- A single oral dose of 3tablets under fasting condition * Period 4: CKD-386(5)- A single oral dose of 1 tablet under fasting condition

Treatment:

Drug: CKD-386(5)

Drug: D013, D326, D337

Sequence 2

Experimental group

Description:

* Period 1: CKD-386(5)- A single oral dose of 1 tablet under fasting condition * Period 2: D013, D326, D337- A single oral dose of 3 tablets under fasting condition * Period 3: CKD-386(5)- A single oral dose of 1 tablet under fasting condition * Period 4: D013, D326, D337- A single oral dose of 3 tablets under fasting condition

Treatment:

Drug: CKD-386(5)

Drug: D013, D326, D337