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NCT04874129 Clinical Trial

Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506

Dyslipidemias Clinical Trial

Official title:
Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04874129
Other study ID # YYPCT_YYC506_102
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date January 7, 2021
Est. completion date July 31, 2021

Study information
Verified date April 2021
Source Yooyoung Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A

Description:

Phase 1 to evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A. Which is designed as ramdomized, oral, single dose, two-way crossover.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date July 31, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years and older
Eligibility Inclusion Criteria: - Over 19 ages healthy men - Over 50.0kg, 18.0kg/m2 = BMI = 30.0kg/m2 - Men who don't have congenital disease and other cronic disease need to be cared. etc. Exclusion Criteria: - Men who have congenital liver disease (AST, ALT, CK = 2X ULN) - Men who have drunken or eatten something including caffeine within 24 hours before. etc.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• YYC506-T and YYC506-A (phase 1)
Comparator
• YYC506 (phase 1)
Test
• YYC506-T and YYC506-A (phase 2)
Comparator
• YYC506 (phase 2)
Test

Locations
Country Name City State
Korea, Republic of Chungbuk National Unviersity Hosipital Cheongju-si

Sponsors (1)
Lead Sponsor Collaborator
Yooyoung Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetic parameters: Cmax Cmax Until 48 hours
Primary Pharmacokinetic parameters: AUC YYC506-T, YYC506-A, YYC506 AUC Until 48 hours
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