Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg)

Samyang Biopharmaceuticals Corporation24 enrolled

Overview

The purpose of this study is to evaluate the bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg) in single dose oral administration.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperlipidemia

Interventions

Sequence 1DRUG

fenofibrate 65mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral → fenofibrate 160mg, fed condition, per oral

Sequence 2DRUG

fenofibrate 65mg, fed condition, per oral → fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral

Seqeunce 3DRUG

fenofibrate 65mg, fasting condition, per oral → fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fed condition, per oral

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adults 20-50 years of age * Weight more than 55kg and within ±20% IBW(Ideal Body Weight) * Voluntary written informed consent Exclusion Criteria: * History or presence of significant renal, neurologic, pulmonary, endocrine, hematology, oncology, urologic, cardiovascular, musculoskeletal or psychiatric disease * Drug allergies to fenofibrate * Recent history or evidence of drug abuse * Recent participation(within 2months) in other clinical studies * Recent donation of blood(within 2months) or plasma(within 1months)

Locations (1)

Clinical Research Institute, Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg)

Time frame: 23 days

Data from ClinicalTrials.gov

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