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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Dietary Supplement: High fat meal
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Further study details as provided by DreamPharma:

Primary Outcome Measures:
  • Composite of Pharmacokinetics(Cmax, AUClast) [ Time Frame: 24h ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: July 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High fat meal Dietary Supplement: High fat meal
offer high fat-meal in the morning before drug intake.
Other Names:
  • Other Names:
  • DP-R202 : DP11002-3
Experimental: DP-R202
under fed condition
 Dietary Supplement: High fat meal
offer high fat-meal in the morning before drug intake.
Other Names:
  • Other Names:
  • DP-R202 : DP11002-3

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20 to 55 years of healthy volunteers

Exclusion Criteria:

  • Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421576

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Gangnam, Korea, Republic of, 135-710
Sponsors and Collaborators
DreamPharma
Investigators
Principal Investigator: Jae Wook Ko, M.D., Ph.D Samsung Medical Center
  More Information

No publications provided

Responsible Party: DreamPharma
ClinicalTrials.gov Identifier: NCT01421576     History of Changes
Other Study ID Numbers: DP-SACL-I-002
Study First Received: August 9, 2011
Last Updated: August 22, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on May 23, 2013