Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers

Study Overview
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Brief Summary
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Study to Evaluate the Safety and Pharmacokinetics of CKD-349

Detailed Description
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An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers

Official Title
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An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Drug: D113
* Drug: CKD-349


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult volunteers aged ≥ 19 years Weight ≥50kg (man) or 45kg (woman), 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 until 7 days after 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 clinically significant diseases or history in digestive systems, cardiovascular system, endocrine system, respiratory system, blood·tumor, infectious disease, kidney and urogenital system, mental·nervous system, musculoskeletal system, immune system, otolaryngology, skin system, ophthalmology system, etc. 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 or take drugs that may interfere with this clinical trials within 10 day before the first administration 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 within 8 weeks or donated ingredients within 2 weeks, or received a blood transfusion within 4 weeks. Those who exceed an alcohol and cigarette consumption than below criteria A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) B. Smoking: 20 cigarettes/day Those who overreacts to the ingredient of this drug and is administering an angiotensin conversion enzyme (ACE) inhibitor or has not passed 36 hours since discontinuation of administration and has a history of vascular edema when administering an angiotensin conversion enzyme (ACE) inhibitor or an angiotensin receptor antagonist (ARB). 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 1<br>Period 1: D113/ Period 2: CKD-349 | Drug: D113<br>* QD, PO<br>Drug: CKD-349<br>* QD, PO<br>|
| Experimental: Sequence2<br>Period 1: CKD-349/ Period 2: D113 | Drug: D113<br>* QD, PO<br>Drug: CKD-349<br>* QD, PO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt of CKD-349 | AUCt: Area under the concentration-time curve from time zero to time | 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours | 
| Cmax of CKD-349 | Cmax: Maximum plasma concentration of the drug | 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of CKD-349 | Area under the concentration-time curve from zero up to ∞ | 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours | 
| Tmax of CKD-349 | Time to maximum plasma concentration | 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours | 
| AUCt/AUCinf of CKD-349 | AUCt/AUCinf | 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours | 
| T1/2 of CKD-349 | Terminal elimination half-life | 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours |