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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04874129
Recruitment Status : Active, not recruiting
First Posted : May 5, 2021
Last Update Posted : May 5, 2021
Sponsor:
Information provided by (Responsible Party):
Yooyoung Pharmaceutical Co., Ltd.

Study Description
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Brief Summary:
To evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A

Condition or disease Intervention/treatment Phase
Dyslipidemias Drug: YYC506-T and YYC506-A (phase 1) Drug: YYC506 (phase 1) Drug: YYC506-T and YYC506-A (phase 2) Drug: YYC506 (phase 2) Phase 1

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: ramdomized, open-label, single-dose, two-way crossover study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506
Actual Study Start Date : January 7, 2021
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : July 31, 2021
Arms and Interventions
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Arm Intervention/treatment
A Group
Two-way Crossover
 Drug: YYC506-T and YYC506-A (phase 1)
Comparator
Other Name: Comparator

Drug: YYC506 (phase 2)
Test
Other Name: Test
B Group
Two-way Crossover
 Drug: YYC506 (phase 1)
Test
Other Name: Test

Drug: YYC506-T and YYC506-A (phase 2)
Comparator
Other Name: Comparator


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetic parameters: Cmax [ Time Frame: Until 48 hours ]
    Cmax

  2. Pharmacokinetic parameters: AUC [ Time Frame: Until 48 hours ]
    YYC506-T, YYC506-A, YYC506 AUC


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04874129


Locations
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Korea, Republic of
Chungbuk National Unviersity Hosipital
Cheongju-si, Korea, Republic of
Sponsors and Collaborators
Yooyoung Pharmaceutical Co., Ltd.
Investigators
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Study Chair: Min Kyu Park, PhD Chungbuk National University Hosipital.
More Information
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Responsible Party: Yooyoung Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04874129    
Other Study ID Numbers: YYPCT_YYC506_102
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases