Bioavailability Study of DP-R202 in Healthy Male Volunteers Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DreamPharma
ClinicalTrials.gov Identifier:
NCT01421576
First received: August 9, 2011
Last updated: August 22, 2011
Last verified: August 2011

August 9, 2011
August 22, 2011
July 2011
July 2011   (final data collection date for primary outcome measure)
Composite of Pharmacokinetics(Cmax, AUClast) [ Time Frame: 24h ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01421576 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

The number of patient is twenty-four.Patients were randomly assigned either DP-R202(Sarpogrelate HCL 300mg, qd) under fasting condition or DP-R202(Sarpogrelate HCL 300mg, qd) after eating foods.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
Dietary Supplement: High fat meal
offer high fat-meal in the morning before drug intake.
Other Names:
  • Other Names:
  • DP-R202 : DP11002-3
  • Active Comparator: High fat meal
    Intervention: Dietary Supplement: High fat meal
  • Experimental: DP-R202
    under fed condition
    Intervention: Dietary Supplement: High fat meal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 20 to 55 years of healthy volunteers

Exclusion Criteria:

  • Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets
Male
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01421576
DP-SACL-I-002
No
DreamPharma
DreamPharma
Not Provided
Principal Investigator: Jae Wook Ko, M.D., Ph.D Samsung Medical Center
DreamPharma
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP