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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01421576
First Posted: August 23, 2011
Last Update Posted: August 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alvogen Korea
August 9, 2011
August 23, 2011
August 23, 2011
July 2011
July 2011   (Final data collection date for primary outcome measure)
Composite of Pharmacokinetics(Cmax, AUClast) [ Time Frame: 24h ]
Same as current
No Changes Posted
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
Intervention Model: Crossover Assignment
Masking: None (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
Sexes Eligible for Study: Male
20 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01421576
DP-SACL-I-002
No
Not Provided
Not Provided
Alvogen Korea
Alvogen Korea
Not Provided
Principal Investigator: Jae Wook Ko, M.D., Ph.D Samsung Medical Center
Alvogen Korea
August 2011

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