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Study to Evaluate the Safety and Pharmacokinetics of CKD-331 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study to Evaluate the Safety and Pharmacokinetics of CKD-331

An Open-label, Randomized, Single-dose, 2-sequence, 4-period, Cross-over, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-331 in Healthy Adult Volunteers

NCT05335044•Chong Kun Dang Pharmaceutical

View on ClinicalTrials.gov

Summary

Phase 1 study to evaluate the safety and pharmacokinetics of CKD-331 in healthy adult volunteers

Detailed Description

An open-label, randomized, single-dose, 2-sequence, 4-period, cross-over, phase 1 study to evaluate the safety and pharmacokinetics of CKD-331 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 have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
•4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
•5. Those who agree to contraception during the participation of clinical trial.
•6. 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 have no medical history of digestive disease, cardiovascular disease, endocrine disease, respiratory system, blood·tumor disease, infection disease, nephrology disease, genitourinary disease, neuron disease, skeletal disease, immunological disease, otolaryngological disease, dermatological disease, ophiological disease
•2. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
•3. 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.
•4. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
•5. Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.
•6. 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
•7. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
•8. Those who are deemed insufficient to participate in this clinical study by investigators.
+1 more criteria

Locations (1)

H plus Yangji hospital

Seoul, South Korea

Key Dates

Start Date

May 31, 2022

Primary Completion Date

June 23, 2022

Completion Date

July 12, 2022

Last Updated

June 9, 2023

Enrollment

ACTUAL participants

Conditions

Hypertension and Dyslipidemia

Interventions

CKD-331

DRUG

EX5619

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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 9, 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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