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

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Type II Diabetes

Treatments: Drug: CKD-393 formulation II; Drug: CKD-393 formulation I; Drug: D501, D759, H053

Study type: Interventional

Funder types: Industry

Identifiers

NCT04768673

A98_04BE2022P

Details and patient eligibility

About

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

Full description

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

Enrollment: 26 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

[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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 6 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: CKD-393 formulation II

Drug: CKD-393 formulation I

Drug: D501, D759, H053

Group 2

Experimental group

Description:

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

Treatment:

Drug: CKD-393 formulation II

Drug: CKD-393 formulation I

Drug: D501, D759, H053

Group 3

Experimental group

Description:

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

Treatment:

Drug: CKD-393 formulation II

Drug: CKD-393 formulation I

Drug: D501, D759, H053

Group 4

Experimental group

Description:

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

Treatment:

Drug: CKD-393 formulation II

Drug: CKD-393 formulation I

Drug: D501, D759, H053

Group 5

Experimental group

Description:

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

Treatment:

Drug: CKD-393 formulation II

Drug: CKD-393 formulation I

Drug: D501, D759, H053

Group 6

Experimental group

Description:

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

Treatment:

Drug: CKD-393 formulation II

Drug: CKD-393 formulation I

Drug: D501, D759, H053