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Pharmacokinetic / Pharmacodynamic (PK/PD) Study of Multiple Doses of DP-R202 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01429688
Recruitment Status : Completed
First Posted : September 7, 2011
Last Update Posted : September 7, 2011
Sponsor:
Information provided by (Responsible Party):
Alvogen Korea

Brief Summary:
The purpose of this study is compare the safety and pharmacokinetic characteristics of DP-R202 (Sarpogrelate HCl 100mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid) after multiple oral administration in healthy male volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: Anplag Phase 1

Detailed Description:
The number of patient is thirthy-six.Patients were randomly assigned either anplag tablet(Sarpogrelate HCL 100mg, tid)3days first, DP-R202(Sarpogrelate HCL 300mg, qd) 3days Second or DP-R202(Sarpogrelate HCL 300mg, qd)3days first, anplag tablet(Sarpogrelate HCL 100mg, tid) 3days second.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : July 2011
Primary Completion Date : August 2011
Study Completion Date : August 2011

Arm Intervention/treatment
Experimental: DP-R202
Multiple oral administration for 3 days
Drug: Anplag
Sarpogrelate HCl 300mg once a day or 100mg three times a day for 3 days
Other Names:
  • Other Names:
  • DP-R202 : DP11002-3
  • Anplag : 0007-1
Active Comparator: Anplag
Multiple oral administration for 3days
Drug: Anplag
Sarpogrelate HCl 300mg once a day or 100mg three times a day for 3 days
Other Names:
  • Other Names:
  • DP-R202 : DP11002-3
  • Anplag : 0007-1



Primary Outcome Measures :
  1. Composite of pharmacokinetics [ Time Frame: comparator 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 6.33, 6.67, 7, 7.5, 8, 9, 12, 12.33, 12.67, 13, 13.5, 14, 15, 16, 24h Test drug : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24h ]
    Cmax, ss, AUCτ


Secondary Outcome Measures :
  1. Composite of pharmacokinetics [ Time Frame: comparator 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 6.33, 6.67, 7, 7.5, 8, 9, 12, 12.33, 12.67, 13, 13.5, 14, 15, 16, 24h Test drug : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24h ]
    tmax,ss, t1/2, Cav,ss, PTF, AI, Cmin,ss



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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

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): NCT01429688


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Alvogen Korea
Investigators
Principal Investigator: Jae Wook Ko, MD, PhD Samsung Medical Center

Responsible Party: Alvogen Korea
ClinicalTrials.gov Identifier: NCT01429688     History of Changes
Other Study ID Numbers: DP-SACL-I-003
First Posted: September 7, 2011    Key Record Dates
Last Update Posted: September 7, 2011
Last Verified: September 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