A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(2) 80/20/10mg

Phase 1

Completed

• Conditions: Hypertension and Dyslipidemia
• Interventions: Drug: CKD-386(2); Drug: D013, D326, D337

• Registration Number: NCT04987970
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-386(2)

Detailed Description

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

Study Timeline

• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-08-03
• Study Start: 2021-09-12
• Primary Completion: 2021-11-11
• Study Completion: 2021-11-27
• Status Verified: 2021-12
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Healthy adult volunteers aged ≥ 19 years

2. Weight ≥50kg (man) or 45kg (woman), 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.

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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 take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products.

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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
AUCt of CKD-386(2)	Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours	Area under the concentration-time curve from time zero to time
Cmax of CKD-386(2)	Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours	Maximum plasma concentration of the drug

Secondary Outcome Measures

Name	Time	Method
Tmax of CKD-386(2)	Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours	Time to maximum plasma concentration
T1/2 of CKD-386(2)	Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours	Terminal elimination half-life
AUCinf of CKD-386(2)	Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours	Area under the concentration-time curve from zero up to ∞
AUCt/AUCinf of CKD-386(2)	Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours	AUCt/AUCinf

Trial Locations

Locations (1)

H plus Yangji hospital; 🇰🇷 Seoul, Korea, Republic of