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

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04874129
Enrollment
60
Registered
2021-05-05
Start date
2021-01-07
Completion date
2021-07-31
Last updated
2021-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias

Brief summary

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

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.

Interventions

DRUGYYC506-T and YYC506-A (phase 1)

Comparator

DRUGYYC506 (phase 1)

Test

DRUGYYC506-T and YYC506-A (phase 2)

Comparator

DRUGYYC506 (phase 2)

Test

Sponsors

Yooyoung Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

ramdomized, open-label, single-dose, two-way crossover study

Eligibility

Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pharmacokinetic parameters: CmaxUntil 48 hoursCmax
Pharmacokinetic parameters: AUCUntil 48 hoursYYC506-T, YYC506-A, YYC506 AUC

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026