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Clinical Trial to Investigate the Pharmacokinetics and Safety of CKD-393 | Clinical Trials | Clareo Health

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Clinical Trial to Investigate the Pharmacokinetics and Safety of CKD-393

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety of CKD-393 and Co-administration of CKD-501, D759 and D150 Under Fed Condition in Healthy Adults

NCT04706286•Chong Kun Dang Pharmaceutical

View on ClinicalTrials.gov

Summary

A Clinical Trial to evaluate the Pharmacokinetics and safety of CKD-393 0.5/100/1000 mg under fed condition

Detailed Description

A Phase 1 Clinical Trial to evaluate the safety and pharmacokinetics in healthy adult volunteers after administration of CKD-393 0.5/100/1000 mg under fed condition.

Eligibility

Age

19 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy adult who is 19 \~ 55 years at the time of screening
•2. Body weight more than 55 kg for male and more than 50kg for female
•3. BMI more than 18.5 kg/m2 or less than 27.0 kg/m2
•4. Females must be menopause or surgical infertility
•5. Males who have consented to the use of appropriate pregnancy contraceptive methods up to 28 days after the last investigational product and not to provide sperm
•6. Subjects who voluntarily decided to participate and informed consent based upon understanding on the study.

Exclusion Criteria

•1. Subjects who have a history of clinically significant hepatic, renal, nervous, immune, respiratory, urinary, digestion, endocrine, hematooncology, cardiovascular systemic disease or psychosis disorder
•2. Subjects who have genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
•3. Subjects with poor oral intake, susceptible to dehydration or clinically significant dehydration
•4. Subjects who have a history of gastrointestinal disorders (Crohn's disease, ulcerative colitis, etc.) or surgery (except simple appendectomy or hernia surgery) that may affect the absorption of the drug
•5. Subjects who have a history of clinically significant hypersensitivity to drugs or additives
•6. Subjects who have severe infectious disease and severe trauma before and after operation
•7. Subjects who have undergone i.v. testing of radioactive iodine contrast material within 48 hours before the first IP administration
•8. Subjects who are deemed unsuitable as subjects in the screening test performed within 28 days before the administration of investigational product
•* AST, ALT\> UNL(Upper Normal Limit)x1.25
•* eGFR (Estimated Glomerular Filtration Rate) \<60 mL/min/1.73m2 using the MDRD (Modification of Diet in Renal Disease) equation
+14 more criteria

Locations (1)

Severance Hospital

Seoul, South Korea

Key Dates

Start Date

February 18, 2021

Primary Completion Date

March 29, 2021

Completion Date

April 5, 2021

Last Updated

January 12, 2021

Enrollment

ESTIMATED participants

Conditions

T2DM (Type 2 Diabetes Mellitus)

Interventions

CKD-501, D759, D150

DRUG

CKD-393 0.5/100/1000 mg

DRUG

Contacts

Choon Ok Kim, M.D., Ph.D.

CONTACT

+82-2-2228-0455 DELIVERY98@yuhs.ac

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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 12, 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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Clinical Trial to Investigate the Pharmacokinetics and Safety of CKD-393

Inclusion Criteria

Exclusion Criteria

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