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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DreamPharma
ClinicalTrials.gov Identifier:
NCT01421563
First received: July 27, 2011
Last updated: August 22, 2011
Last verified: August 2011
  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
Endpoint Classification: Pharmacokinetics Study
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 DreamPharma:

Primary Outcome Measures:
  • Cmax, AUClast [ Time Frame: 24h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • tmax, t1/2, AUC0-∞ [ Time Frame: 24h ] [ Designated as safety issue: No ]

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

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: NCT01421563

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

No publications provided

Responsible Party: DreamPharma
ClinicalTrials.gov Identifier: NCT01421563     History of Changes
Other Study ID Numbers: DP-SACL-I-001
Study First Received: July 27, 2011
Last Updated: August 22, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on July 24, 2014