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A Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348

Phase I Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348 With Co-administration of CKD-828, D097 and D337 in Healthy Adult Volunteers

NCT04258865•Chong Kun Dang Pharmaceutical

View on ClinicalTrials.gov

Summary

A clinical trial to compare the pharmacokinetics and tolerability of CKD-348

Detailed Description

A randomized, open-label, single-dose, 3-way crossover clinical trial to compare the pharmacokinetics and tolerability of CKD-348 with co-administrated drugs in healthy adult volunteers

Eligibility

Age

19 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy adult volunteers aged ≥ 19-year-old
•2. Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
•3. Those who are eligible for adequate 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 chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
•5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
•6. Those who agree to contraception during the participation of clinical trial
•7. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

Exclusion Criteria

•1. Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
•2. Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug
•3. Those who donated whole blood and apheresis within 2 months or received transfusion within 1 month
•4. Those who has a history of gastrointestinal surgery (
•5. Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30mL) Smoke: 20 cigarettes/day
•6. Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, shock, dihydropyridine sensitivity, angioedema, cardiac insufficiency
•7. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
•8. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
•9. Women who are pregnant or who may be pregnant and breastfeed

Locations (1)

H Plus Yangji Hospital

Seoul, Gwanak-gu, South Korea

Key Dates

Start Date

March 25, 2020

Primary Completion Date

April 26, 2020

Completion Date

May 13, 2020

Last Updated

June 5, 2020

Enrollment

ACTUAL participants

Conditions

HypertensionDyslipidemias

Interventions

CKD-348 F1

DRUG

CKD-348 F2

DRUG

CKD-828, D097, D337

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITING

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

NCT07480265

Hypertension (HTN)Hyperhomocysteinemia+1 more

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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: June 5, 2020Data 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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A Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

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