Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 Under Fed Condition

Chong Kun Dang

Status and phase: Unknown; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: D635; Drug: CKD-387

Study type: Interventional

Funder types: Industry

Identifiers

NCT03849339

184BE18028

Details and patient eligibility

About

The purpose of the clinical trail is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D635 under fed condition in healthy adults.

Enrollment: 20 estimated patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adults aged 19 to 55 years
2. Females must be menopause or surgical infertility
3. Signed informed consent form
4. Other inclusion criteria, as defined in the protocol

Exclusion criteria

1. History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder

2. Clinical laboratory test values are outside the accepted normal range at Screening

   • aspartate aminotransferase(AST), alanine aminotransferase(ALT) > 1.25 times the upper limit of the normal range
   • Total Bilirubin > 1.5 times the upper limit of the normal range
   • creatine phosphokinase(CPK) > 1.5 times the upper limit of the normal range
   • estimated Glomerular Filtration Rate(eGFR, MDRD* formula) < 60 mL/min/1.73m2 (*MDRD: Modification of Diet in Renal Disease)
   • Positive reaction on following tests: Hepatitis B, Hepatitis C, human immunodeficiency virus(HIV) and syphilis
   • systolic blood pressure(SBP) ≥ 150 mmHg or < 90 mmHg, diastolic blood pressure(DBP) > 100 mmHg or < 50 mmHg

3. Subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization

4. Participated in a clinical trial within 90 days prior to 1st IP dosing

5. Not eligible to participate for the study at the discretion of Investigator

6. Other exclusive inclusion criteria, as defined in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Group 1

Experimental group

Description:

* Period 1: D635 * Period 2: CKD-387

Treatment:

Drug: D635

Drug: CKD-387

Group 2

Experimental group

Description:

* Period 1: CKD-387 * Period 2: D635

Treatment:

Drug: D635

Drug: CKD-387