Study to Evaluate the Safety and Pharmacokinetics of CKD-331

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

Detailed Description
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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

Official Title
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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

Conditions
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Hypertension and Dyslipidemia

Intervention / Treatment
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* Drug: CKD-331
* Drug: EX5619


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult volunteers aged ≥ 19 years Weight ≥55kg with calculated body mass index (BMI) of 18 to 30 kg/m2 Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening. Those who agree to contraception during the participation of clinical trial. 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: 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 Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery. 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. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs. Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month. 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 Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption. Those who are deemed insufficient to participate in this clinical study by investigators. Woman who are pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>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 | Drug: CKD-331<br>* QD, PO<br>Drug: EX5619<br>* QD, PO<br>|
| Experimental: Sequence B<br>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 | Drug: CKD-331<br>* QD, PO<br>Drug: EX5619<br>* QD, PO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of CKD-331 | Cmax: Maximum plasma concentration of the drug | Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 34 hours | 
| AUCt of CKD-331 | AUCt: Area under the concentration-time curve from time zero to time | Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 34 hours |