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
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014