Study to Evaluate the Safety and Pharmacokinetics of CKD-331

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

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2022-07-12

Brief Summary

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

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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

Conditions

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Hypertension and Dyslipidemia

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 A

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

Group Type EXPERIMENTAL

CKD-331

Intervention Type DRUG

QD, PO

EX5619

Intervention Type DRUG

QD, PO

Sequence B

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

Group Type EXPERIMENTAL

CKD-331

Intervention Type DRUG

QD, PO

EX5619

Intervention Type DRUG

QD, PO

Interventions

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CKD-331

QD, PO

Intervention Type DRUG

EX5619

QD, PO

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes