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

Samyang Biopharmaceuticals Corporation

Status and phase: Completed; Phase 1

Conditions: Hyperlipidemia

Treatments: Drug: Sequence 4; Drug: Sequence 5; Drug: Seqeunce 3; Drug: Sequence 6; Drug: Sequence 2; Drug: Sequence 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01353404

SYO0805

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

fenofibrate 65mg, fed condition, per oral

Experimental group

Treatment:

Drug: Sequence 2

Drug: Seqeunce 3

Drug: Sequence 6

Drug: Sequence 4

Drug: Sequence 5

Drug: Sequence 1

fenofibrate 65mg, fasting condition, per oral

Experimental group

Treatment:

Drug: Sequence 2

Drug: Seqeunce 3

Drug: Sequence 6

Drug: Sequence 4

Drug: Sequence 5

Drug: Sequence 1

fenofibrate 160mg, fed condition, per oral

Active Comparator group

Treatment:

Drug: Sequence 2

Drug: Seqeunce 3

Drug: Sequence 6

Drug: Sequence 4

Drug: Sequence 5

Drug: Sequence 1