Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-370 and D745 in Healthy Adults

Chong Kun Dang

Status and phase: Unknown; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: CKD-370; Drug: D745

Study type: Interventional

Funder types: Industry

Identifiers

NCT03849495

191BE18033

Details and patient eligibility

About

A randomized, open-label, single dose, two-way crossover study to compare the pharmacokinetics and safety/tolerability of CKD-370 with D745 in healthy volunteers

Enrollment: 28 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adults aged 19 to 55 years
2. Females who are not pregnant or breastfeeding or who have 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, digestive, urinary, 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) > 1.5 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. Current smokers or those who cannot quit smoking during the period from 90 days before the first IP dosing to the last discharge.

4. Subject who drink excessive caffeine or alcohol continuously and who cannot discontinue caffeine or alcohol intake during the period from 3 days before the first IP dosing to the last discharge.

5. Participated in a clinical trial within 90 days prior to first IP dosing

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

7. 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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28 participants in 2 patient groups

Group A

Experimental group

Description:

Period 1: D745 Period 2: CKD-370

Treatment:

Drug: D745

Drug: CKD-370

Group B

Experimental group

Description:

Period 1: CKD-370 Period 2: D745

Treatment:

Drug: D745

Drug: CKD-370