The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-375

Chong Kun Dang

Status and phase: Unknown; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: CKD-375; Drug: D387

Study type: Interventional

Funder types: Industry

Identifiers

NCT03848637

192BE18036

Details and patient eligibility

About

The purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-375 and D387 in healthy adults.

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, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
2. Clinical laboratory test values are outside the accepted normal range at Screening
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 1st 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 1

Experimental group

Description:

* Period 1: D387 (reference drug) * Period 2: CKD-387 (test drug)

Treatment:

Drug: CKD-375

Drug: D387

Group 2

Experimental group

Description:

* Period 1: CKD-387 (test drug) * Period 2: D387 (reference drug)

Treatment:

Drug: CKD-375

Drug: D387