A Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions

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

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-21

Study Completion Date

2022-05-09

Brief Summary

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A Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions

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Detailed Description

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A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-393(2) in healthy volunteers under fed conditions

Conditions

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Type2Diabetes

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- A single dose of 4 tablets(CKD-501 1T, D759 1T, D150 1T, D029 1T) under fed condition Period 2- A single dose of 2 tablets(CKD-393(2) 2T) under fed condition

Group Type EXPERIMENTAL

CKD-393(2)

Intervention Type DRUG

QD, PO

CKD-501, D759, D150, D029

Intervention Type DRUG

QD, PO

sequence 2

Period 1- A single dose of 2 tablets(CKD-393(2) 2T) under fed condition Period 2- A single dose of 4 tablets(CKD-501 1T, D759 1T, D150 1T, D029 1T) under fed condition

Group Type EXPERIMENTAL

CKD-393(2)

Intervention Type DRUG

QD, PO

CKD-501, D759, D150, D029

Intervention Type DRUG

QD, PO

Interventions

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CKD-393(2)

QD, PO

Intervention Type DRUG

CKD-501, D759, D150, D029

QD, PO

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy adult volunteers aged 19 ≤ \~ \< 55-year-old.
2. Weight ≥55kg (man) or 45kg (woman), with calculated body mass index(BMI) of 17.5 ≤ \~ \< 30.5 kg/m2.
3. Those who have no congenital diseases or chronic diseases within 3 years 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.

Exclusion Criteria

1. Those who have clinically significant disease or medical history of heart failure, Hepatopathy, Type 1 Diabetes, Diabetic ketoacidosis, Edema, Renal dysfunction, galactose intolerance, glucose-galactose malabsorption. And Those who receive intravenous administration of radioactive iodine contrast agents (for intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) during clinical trial.
2. Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of investigational drug.
3. Those who are pregnant or breastfeeding.
4. Those who are deemed inappropriate to participate in clinical trial by investigators.

Minimum Eligible Age

19 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes