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Clinical Study to Compare the Pharmacokinetics and Safety of D113 With CKD-349 in Healthy Volunteers

A Randomized, Open-label, Single-dosing, 3-treatment, 6-sequence, 3-period, Crossover-design Pilot Clinical Trial to Compare the Safety and Pharmacokinetics of D113 With CKD-349 in Healthy Adult Volunteers

NCT04952506•Chong Kun Dang Pharmaceutical

View on ClinicalTrials.gov

Summary

This study is a randomized, open-label, single dosing, 3-treatment, 6-sequence, 3-period, crossover-design study to compare the pharmacokinetics and safety of D113 with CKD-349 in healthy volunteers.

Detailed Description

To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug: Entresto 200mg / Test drug: 1) CKD-349 F1 Tab. 2) CKD-349 F2 Tab. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy adults over the age of 19 years at the time of screening
•2. Individuals who had 18.5 kg/m2 ≤ Body Mass Index(BMI) \< 29.9kg/m2 and total body weight ≥ 55 kg
•\* BMI = Weight(kg)/ Height(m)2
•3. Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination
•4. Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/bacterial, etc.) and vital signs, ECG etc. performed within 28 days to the scheduled date of first administration of the investigational product
•5. In case of female subjects, those who were confirmed to be non-pregnant at screening
•6. Individuals who agreed to the use of appropriate medically recognized contraceptive methods themselves or their spouse (or partner) from the first administration of the investigational product to the 7th day of last administration. And in case of male subjects, those who agreed not donation of sperm, in case of female subjects, those who agreed not to be pregnant or breast-feeding from the first administration of the investigational product to the 7th day of last administration
•7. Individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical trial.

Exclusion Criteria

•1. Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
•2. Individuals with symptoms of acute disease within 28 days prior to the scheduled date of first administration of the investigational product
•3. Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption
•4. Individuals with a medical history or current symptoms that fall under one or more of the following who are judged to be concerned about the use of investigational product
•* Individuals with hypersensitivity to investigational products or the investigational products ingredients
•* Angiotensin-converting enzyme(ACE) inhibitors are being administered or less than 36hr after discontinuation.
•* Individuals with history of vascular edema in angiotensin-converting enzyme(ACE) inhibitors or angiotensin receptor blocker(ARB) administration
•* Individuals with genetic or idiopathic angioedema
•* Individuals with liver cirrhosis or atresia of bile ducts or cholestasis
•* Individuals with primary hyperaldosteronism
+18 more criteria

Locations (1)

Chungnam National University Hospital

Daejeon, South Korea

Key Dates

Start Date

July 19, 2021

Primary Completion Date

July 29, 2021

Completion Date

August 20, 2021

Last Updated

January 24, 2024

Enrollment

ACTUAL participants

Conditions

Chronic Renal Failure

Interventions

CKD-349 F1 Tab.

DRUG

CKD-349 F2 Tab.

DRUG

D113 Tab.

DRUG

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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: January 24, 2024Data 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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Clinical Study to Compare the Pharmacokinetics and Safety of D113 With CKD-349 in Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

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