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Safety and Pharmacokinetic Characteristics of DP-R202 in Healthy Male Volunteers

This study has been completed.
Information provided by (Responsible Party):
Alvogen Korea Identifier:
First received: July 27, 2011
Last updated: August 22, 2011
Last verified: August 2011
The purpose of this study is compare the safety and pharmacokinetic characteristics of DP-R202 (Sarpogrelate HCl 300mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid) after oral administration in healthy male volunteers.

Condition Intervention Phase
Drug: Anplag
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Randomized, Open-label, Two-Sequence, Two-Period Crossover Study to Assess the Pharmacokinetic Characteristics of Sarpogrelate HCl Controlled Release Tablet Compared With Sarpogrelate HCl Immediate Release Tablet in Healthy Male Subjects

Further study details as provided by Alvogen Korea:

Primary Outcome Measures:
  • Cmax, AUClast [ Time Frame: 24h ]

Secondary Outcome Measures:
  • tmax, t1/2, AUC0-∞ [ Time Frame: 24h ]

Enrollment: 36
Study Start Date: February 2011
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anplag Drug: Anplag
Sarpogrelate HCl 300mg once a day or 100mg three times a day
Other Names:
  • DP-R202 : DP11002-2
  • Anplag : 0007
Experimental: DP-R202 Drug: Anplag
Sarpogrelate HCl 300mg once a day or 100mg three times a day
Other Names:
  • DP-R202 : DP11002-2
  • Anplag : 0007

Detailed Description:
The number of patient is thirthy-six.Patients were randomly assigned either anplag tablet(Sarpogrelate HCL 100mg, tid)first, DP-R202(Sarpogrelate HCL 300mg, qd) Second or DP-R202(Sarpogrelate HCL 300mg, qd) first, anplag tablet(Sarpogrelate HCL 100mg, tid) second.

Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 20 to 55 years of healthy volunteers

Exclusion Criteria:

  • Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets
  Contacts and Locations
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Please refer to this study by its identifier: NCT01421563

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Alvogen Korea
Principal Investigator: JaeWook Ko, M.D., Ph.D. Samsung Medical Center
  More Information

Responsible Party: Alvogen Korea Identifier: NCT01421563     History of Changes
Other Study ID Numbers: DP-SACL-I-001
Study First Received: July 27, 2011
Last Updated: August 22, 2011

Additional relevant MeSH terms:
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on May 22, 2017