The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-375
NCT ID: NCT03848637
Last Updated: 2019-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
28 participants
INTERVENTIONAL
2019-04-14
2019-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group 1
* Period 1: D387 (reference drug)
* Period 2: CKD-387 (test drug)
CKD-375
Test drug
D387
Reference drug
Group 2
* Period 1: CKD-387 (test drug)
* Period 2: D387 (reference drug)
CKD-375
Test drug
D387
Reference drug
Interventions
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CKD-375
Test drug
D387
Reference drug
Eligibility Criteria
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Inclusion Criteria
2. Females who are not pregnant or breastfeeding or who have surgical infertility
3. Signed informed consent form
Exclusion Criteria
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
19 Years
50 Years
ALL
Yes
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Kyung-Sang Yu, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Central Contacts
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Kyung-Sang Yu, M.D.,Ph.D
Role: CONTACT
Other Identifiers
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192BE18036
Identifier Type: -
Identifier Source: org_study_id
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