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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-03

Study Completion Date

2022-04-06

Brief Summary

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Study to Evaluate the Safety and Pharmacokinetics of CKD-349

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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

Conditions

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Chronic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1

Period 1: D113/ Period 2: CKD-349

Group Type EXPERIMENTAL

D113

Intervention Type DRUG

QD, PO

CKD-349

Intervention Type DRUG

QD, PO

Sequence2

Period 1: CKD-349/ Period 2: D113

Group Type EXPERIMENTAL

D113

Intervention Type DRUG

QD, PO

CKD-349

Intervention Type DRUG

QD, PO

Interventions

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D113

QD, PO

Intervention Type DRUG

CKD-349

QD, PO

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy adult volunteers aged ≥ 19 years
2. Weight ≥50kg (man) or 45kg (woman), 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 until 7 days after 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 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.
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 or take drugs that may interfere with this clinical trials within 10 day before the first administration
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 within 8 weeks or donated ingredients within 2 weeks, or received a blood transfusion within 4 weeks.
6. 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
7. 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).
8. Those who are deemed insufficient to participate in this clinical study by investigators.
9. Woman who are pregnant or breastfeeding.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes