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Pharmacokinetics and Food Effect of Sarpogrelate HCl CR Formulation in Comparison to Immediate-release Formulation

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ClinicalTrials.gov Identifier: NCT01841086
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : April 26, 2013
Sponsor:
Information provided by (Responsible Party):
Korea United Pharm. Inc.

Brief Summary:
The purpose of this study is to evaluate the pharmacokinetics of sarpogrelate controlled-release formulation (CR) in comparison to immediate-release formulation (IR) and Food effect on the pharmacokinetics of sarpogrelate CR.

Condition or disease Intervention/treatment Phase
Healthy Drug: Anplag Drug: UI03SPG300CT Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Single Dose, 3-Treatment, 3-Period Williams-Design to Assess the Pharmacokinetic Characteristics and Food Effect of Sarpogrelate HCl CR Tablets Compared With Sarpogrelate HCl IR Tablets in Healthy Male Subjects
Study Start Date : September 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Active Comparator: Anplag
Sarpogrelate HCl 300mg once a day or 100mg three times a day
Drug: Anplag
Sarpogrelate HCl 300mg once a day or 100mg three times a day
Other Name: UI03SPG300CT

Drug: UI03SPG300CT
Sarpogrelate HCl 300mg once a day or 100mg three times a day

Experimental: UI03SPG300CT
Sarpogrelate HCl 300mg once a day or 100mg three times a day
Drug: Anplag
Sarpogrelate HCl 300mg once a day or 100mg three times a day
Other Name: UI03SPG300CT

Drug: UI03SPG300CT
Sarpogrelate HCl 300mg once a day or 100mg three times a day




Primary Outcome Measures :
  1. Cmax [ Time Frame: 24h ]
    Active Comparator : predose(0), 0.25, 0.5, 1, 1.5, 2, 3, 6(immediately before 2nd drug intake) , 6.25, 6.5, 7, 7.5, 8, 9, 12(immediately before 3rd drug intake), 12.5, 13, 13.5, 14, 15, 16, 24 hours post-dose Experimental : predose(0), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 hours post-dose

  2. AUCt [ Time Frame: 24h ]
    Active Comparator : predose(0), 0.25, 0.5, 1, 1.5, 2, 3, 6(immediately before 2nd drug intake) , 6.25, 6.5, 7, 7.5, 8, 9,12(immediately before 3rd drug intake), 12.5, 13, 13.5, 14, 15, 16, 24 hours post-dose Experimental : predose(0), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 hours post-dose


Secondary Outcome Measures :
  1. tmax, t1/2 [ Time Frame: 24h ]
    Active Comparator : predose(0), 0.25, 0.5, 1, 1.5, 2, 3, 6(immediately before 2nd drug intake) , 6.25, 6.5, 7, 7.5, 8, 9, 12(immediately before 3rd drug intake), 12.5, 13, 13.5, 14, 15, 16, 24 hours post-dose Experimental : predose(0), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 hours post-dose

  2. AUC0-∞ [ Time Frame: 24h ]
    Active Comparator : predose(0), 0.25, 0.5, 1, 1.5, 2, 3, 6(immediately before 2nd drug intake) , 6.25, 6.5, 7, 7.5, 8, 9,12(immediately before 3rd drug intake), 12.5, 13, 13.5, 14, 15, 16, 24 hours post-dose Experimental : predose(0), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 hours post-dose



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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): NCT01841086


Sponsors and Collaborators
Korea United Pharm. Inc.
Investigators
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Principal Investigator: Wooseong Huh, M.D., Ph.D. Samsung Medical Center

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Responsible Party: Korea United Pharm. Inc.
ClinicalTrials.gov Identifier: NCT01841086     History of Changes
Other Study ID Numbers: KUP-SPG3-101
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: April 26, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Sarpogrelate
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs