A Study to Investigate the PK and Safety of CKD-393

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-26

Study Completion Date

2021-04-27

Brief Summary

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A clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393

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Detailed Description

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A randomized, open-label, single-dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393 and co-administration of CKD-501, D759 and H053 under fed condition in healthy adults

Conditions

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Type II Diabetes

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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Group 1

Period 1: CKD-501, D759, H053 / Period 2: CKD-393 Formulation I / Period 3: CKD-393 Formulation II

Group Type EXPERIMENTAL

CKD-393 formulation I

Intervention Type DRUG

single, oral administration of 2 tablets under fed condition

CKD-393 formulation II

Intervention Type DRUG

single, oral administration of 2 tablets under fed condition

D501, D759, H053

Intervention Type DRUG

single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition

Group 2

Period 1: CKD-393 Formulation I / Period 2: CKD-393 Formulation II / Period 3: CKD-501, D759, H053

Group Type EXPERIMENTAL

CKD-393 formulation I

Intervention Type DRUG

single, oral administration of 2 tablets under fed condition

CKD-393 formulation II

Intervention Type DRUG

single, oral administration of 2 tablets under fed condition

D501, D759, H053

Intervention Type DRUG

single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition

Group 3

Period 1: CKD-393 Formulation II / Period 2: CKD-501, D759, H053 / Period 3: CKD-393 Formulation I

Group Type EXPERIMENTAL

CKD-393 formulation I

Intervention Type DRUG

single, oral administration of 2 tablets under fed condition

CKD-393 formulation II

Intervention Type DRUG

single, oral administration of 2 tablets under fed condition

D501, D759, H053

Intervention Type DRUG

single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition

Group 4

Period 1: CKD-501, D759, H053 / Period 2: CKD-393 Formulation II / Period 3: CKD-393 Formulation I

Group Type EXPERIMENTAL

CKD-393 formulation I

Intervention Type DRUG

single, oral administration of 2 tablets under fed condition

CKD-393 formulation II

Intervention Type DRUG

single, oral administration of 2 tablets under fed condition

D501, D759, H053

Intervention Type DRUG

single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition

Group 5

Period 1: CKD-393 Formulation I / Period 2: CKD-501, D759, H053 / Period 3: CKD-393 Formulation II

Group Type EXPERIMENTAL

CKD-393 formulation I

Intervention Type DRUG

single, oral administration of 2 tablets under fed condition

CKD-393 formulation II

Intervention Type DRUG

single, oral administration of 2 tablets under fed condition

D501, D759, H053

Intervention Type DRUG

single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition

Group 6

Period 1: CKD-393 Formulation II / Period 2: CKD-393 Formulation I / Period 3: CKD-501, D759, H053

Group Type EXPERIMENTAL

CKD-393 formulation I

Intervention Type DRUG

single, oral administration of 2 tablets under fed condition

CKD-393 formulation II

Intervention Type DRUG

single, oral administration of 2 tablets under fed condition

D501, D759, H053

Intervention Type DRUG

single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition

Interventions

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CKD-393 formulation I

single, oral administration of 2 tablets under fed condition

Intervention Type DRUG

CKD-393 formulation II

single, oral administration of 2 tablets under fed condition

Intervention Type DRUG

D501, D759, H053

single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Between 19 aged and 50 aged healthy adult
2. Body weight more than 55kg for male, more than 50kg for female
3. Body Mass Index over 18.5kg/m2 and under 27.0kg/m2
4. if female, the subject must satisfy more than one of the following:

* subject who have reached menopause (no natural menstruation for at least 2 years.)
* subject who is surgically infertile(hysterectomy or bilateral salpingo-oophorectomy, tubal ligation, or in infertile state under other method)

Exclusion Criteria

1. Subject who is currently with or have diagnosed with clinically significant hepatobiliary(severe hepatopathy, etc.), kidney(severe nephropathy, etc.), neurological, immunologic, respiratory, urinary, gastrointestinal endocrinological(diabetic ketoacidosis, diabetic coma, etc.), hematological, oncological, cardiovascular(heart failure, etc.) or metal illness
2. Subject with one of the following laboratory test results

* AST, ALT \> UNLx1.5
* eGRF \< 60 ml/min/1.73 m2 (MDRD formula)
* immuno-serology test results in positive
* Systolic blood pressure \> 150mmHg or \<90mmHg, Diastolic blood pressure \>100mmHg or \<50mmHg
3. Subject who has history of the following and the history may affect safety of the subject or result of this study

* History of any prescription drug or herbal medicine within 14 days before first administration investigational products
* History of any non-prescription drug including health food, vitamin within 7 days before first administration investigational products
* History of drug-metabolizing induction/inhibition enzyme such as barbital

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes