Bioavailability Study of DP-R202 in Healthy Male Volunteers Under Fed Conditions
A Randomized, Single-dose, 2-sequence, 2-period Crossover Study to Investigate the Food-effect Pharmacokinetics of Sarpogrelate HCl Controlled Release Tablet in Healthy Male Subjects
1 other identifier
interventional
24
1 country
1
Brief Summary
A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect on the pharmacokinetics of DP-R202 tablet after oral administration in healthy male volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Jul 2011
1 active site
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
Study Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 9, 2011
CompletedFirst Posted
Study publicly available on registry
August 23, 2011
CompletedAugust 23, 2011
August 1, 2011
Same day
August 9, 2011
August 22, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Composite of Pharmacokinetics(Cmax, AUClast)
24h
Study Arms (2)
High fat meal
ACTIVE COMPARATORDP-R202
EXPERIMENTALunder fed condition
Interventions
offer high fat-meal in the morning before drug intake.
Eligibility Criteria
You may qualify if:
- to 55 years of healthy volunteers
You may not qualify if:
- Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alvogen Korealead
Study Sites (1)
Samsung Medical Center
Seoul, Gangnam, 135-710, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Jae Wook Ko, M.D., Ph.D
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2011
First Posted
August 23, 2011
Study Start
July 1, 2011
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
August 23, 2011
Record last verified: 2011-08