Study to Evaluate the Safety and Pharmacokinetics of CKD-331

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Hypertension and Dyslipidemia

Treatments: Drug: EX5619; Drug: CKD-331

Study type: Interventional

Funder types: Industry

Identifiers

NCT05335044

A124_01BE2203

Details and patient eligibility

About

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

Full 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

Enrollment: 47 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

9. Woman who are pregnant or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Sequence A

Experimental group

Description:

Period 1: EX5619 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-331 - A single oral dose of 2 tablets under fasting condition Period 3: EX5619 - A single oral dose of 1 tablet under fasting condition Period 4: CKD-331 - A single oral dose of 2 tablets under fasting condition

Treatment:

Drug: EX5619

Drug: CKD-331

Sequence B

Experimental group

Description:

Period 1: CKD-331 - A single oral dose of 2 tablets under fasting condition Period 2: EX5619 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-331 - A single oral dose of 2 tablets under fasting condition Period 4: EX5619 - A single oral dose of 1 tablet under fasting condition

Treatment:

Drug: EX5619

Drug: CKD-331