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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01421563
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
  Purpose
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
Healthy Drug: Anplag Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01421563


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

Responsible Party: Alvogen Korea
ClinicalTrials.gov Identifier: NCT01421563     History of Changes
Other Study ID Numbers: DP-SACL-I-001
First Submitted: July 27, 2011
First Posted: August 23, 2011
Last Update Posted: August 23, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Sarpogrelate
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs