NCT01353404

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2011

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

December 18, 2012

Status Verified

December 1, 2012

Enrollment Period

2 months

First QC Date

May 12, 2011

Last Update Submit

December 16, 2012

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

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

    23 days

Study Arms (3)

fenofibrate 65mg, fed condition, per oral

EXPERIMENTAL
Drug: Sequence 1Drug: Sequence 2Drug: Seqeunce 3Drug: Sequence 4Drug: Sequence 5Drug: Sequence 6

fenofibrate 65mg, fasting condition, per oral

EXPERIMENTAL
Drug: Sequence 1Drug: Sequence 2Drug: Seqeunce 3Drug: Sequence 4Drug: Sequence 5Drug: Sequence 6

fenofibrate 160mg, fed condition, per oral

ACTIVE COMPARATOR
Drug: Sequence 1Drug: Sequence 2Drug: Seqeunce 3Drug: Sequence 4Drug: Sequence 5Drug: Sequence 6

Interventions

Sequence 1DRUG

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

fenofibrate 160mg, fed condition, per oralfenofibrate 65mg, fasting condition, per oralfenofibrate 65mg, fed condition, per oral
Sequence 2DRUG

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

fenofibrate 160mg, fed condition, per oralfenofibrate 65mg, fasting condition, per oralfenofibrate 65mg, fed condition, per oral
Seqeunce 3DRUG

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

fenofibrate 160mg, fed condition, per oralfenofibrate 65mg, fasting condition, per oralfenofibrate 65mg, fed condition, per oral
Sequence 4DRUG

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

fenofibrate 160mg, fed condition, per oralfenofibrate 65mg, fasting condition, per oralfenofibrate 65mg, fed condition, per oral
Sequence 5DRUG

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

fenofibrate 160mg, fed condition, per oralfenofibrate 65mg, fasting condition, per oralfenofibrate 65mg, fed condition, per oral
Sequence 6DRUG

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

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

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults 20-50 years of age
  • Weight more than 55kg and within ±20% IBW(Ideal Body Weight)
  • Voluntary written informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Institute, Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Kyung-Sang Yu, M.D., Ph.D., M.B.A.

    Clinical Research Institute, Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2011

First Posted

May 13, 2011

Study Start

June 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

December 18, 2012

Record last verified: 2012-12

Locations

KR(1)