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

COMPLETEDPHASE1

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

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

NCT05698043•Chong Kun Dang Pharmaceutical

View on ClinicalTrials.gov

Summary

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

Detailed 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

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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
+11 more criteria

Locations (1)

H plus Yangji hospital

Seoul, South Korea

Key Dates

Start Date

July 17, 2023

Primary Completion Date

September 1, 2023

Completion Date

September 26, 2023

Last Updated

November 1, 2023

Enrollment

ACTUAL participants

Conditions

Hypertension and Dyslipidemia

Interventions

CKD-386(5)

DRUG

D013, D326, D337

DRUG

Study to Evaluate the Safety and Pharmacokinetics of CKD-331

NCT05335044

Hypertension and Dyslipidemia

View study

COMPLETEDPHASE1

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

NCT04673864

Hypertension and Dyslipidemia

View study

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: November 1, 2023Data 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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