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

• Sponsor: Chong Kun Dang Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04987970
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.5
• Patients Per Site Per Month: 24

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension and Dyslipidemia	Drug: CKD-386(2); Drug: D013, D326, D337	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Sep 12, 2021
• Actual Primary Completion Date: Nov 11, 2021
• Actual Study Completion Date: Nov 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 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	Drug: CKD-386(2); QD, PO; Drug: D013, D326, D337; QD, PO
Experimental: Sequence 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	Drug: CKD-386(2); QD, PO; Drug: D013, D326, D337; QD, PO

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. 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 ∞

2. 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

3. 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

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

1. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.

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

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

4. 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 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

1. 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

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

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

3. Woman who are pregnant or breastfeeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H plus Yangji hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Chong Kun Dang Pharmaceutical

Investigators

• Principal Investigator: Jaewoo Kim, M.D., PhD., Seoul, Gwanak-gu, South Korea, 08779

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chong Kun Dang Pharmaceutical
• ClinicalTrials.gov Identifier: NCT04987970
• Other Study ID Numbers: A83_07BE2117
• First Posted: Aug 3, 2021
• Last Update Posted: Feb 3, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dyslipidemias

Study Results

No Results Posted as of Feb 3, 2022