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

• Status: Unknown status
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical

Criteria

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