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A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386

An Open Label, Randomized, Single Dose, 2-sequence, 4-period, Cross-over Clinical Trial to Evaluate the Pharmacokinetics and Tolerability of CKD-386 With Co-administration of D012, D326, and D337 in Healthy Adult Volunteers

NCT04673864•Chong Kun Dang Pharmaceutical

View on ClinicalTrials.gov

Summary

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

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 with co-administration of D012, D326, and D337 in healthy adult volunteers

Eligibility

Age

19 - No limit years

Sex

ALL

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
•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 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 2 months or 1 month respectfully, or received blood transfusion within a month.
•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)
•* Smoking: 20 cigarettes/day
•6. Patients with the following diseases
•* Patients with hypersensitivity to the main constituents or components of the investigational drug
+12 more criteria

Locations (1)

H Plus Yangji Hospital

Seoul, Gwanak-gu, South Korea

Key Dates

Start Date

January 17, 2021

Primary Completion Date

March 4, 2021

Completion Date

March 30, 2021

Last Updated

July 7, 2021

Enrollment

ACTUAL participants

Conditions

Hypertension and Dyslipidemia

Interventions

CKD-386

DRUG

D012, D326, D337

DRUG

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

NCT05698043

Hypertension and Dyslipidemia

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COMPLETEDPHASE1

Study to Evaluate the Safety and Pharmacokinetics of CKD-331

NCT05335044

Hypertension and Dyslipidemia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 7, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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