Pharmacokinetics & Safety Study of Clopidogrel 75mg and Aspirin 100mg Coadministration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01526122
First received: January 11, 2012
Last updated: February 1, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to compare characteristics and safety after oral administration of G0041(75/100mg) 2 tablets with those of Clopidogrel 75mg 2 tablets & Aspirin 100mg 2 capsules coadministration in healthy male volunteers.


Condition Intervention Phase
Atherosclerosis
Drug: G0041(75/100mg)
Drug: Clopidogrel & Aspirin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A PhaseⅠ Study to Compare the Pharmacokinetic Characteristics and Safety After Oral Administration of G0041(75/100mg) With Those of Clopidogrel 75mg & Aspirin 100mg Coadministration in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by Dong-A Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • C(max) of Clopidogrel [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ] [ Designated as safety issue: No ]
  • AUC(last) of Clopidogrel [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ] [ Designated as safety issue: No ]
  • C(max) of Acetylsalicylic acid [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ] [ Designated as safety issue: No ]
  • AUC(last) of Acetylsalicylic acid [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • C(max) of Salicylic acid [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ] [ Designated as safety issue: No ]
  • AUC(last) of Salicylic acid [ Time Frame: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: G0041(75/100mg) Drug: G0041(75/100mg)
G0041(75/100mg) 2 capsules(Clopidogrel 75mg & Aspirin 100mg in 1 capsule), PO
Active Comparator: Clopidogrel & Aspirin Drug: Clopidogrel & Aspirin
Clopidogrel 75mg 2 tablets & Aspirin 100mg 2 capsules, PO

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male volunteers between the ages of 20 to 50 years old
  • weight more than 55kg and within the range of ±20% of IBW
  • having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
  • doctor determines to be suitable as subjects within 3 weeks ago before administration

Exclusion Criteria:

  • Hypersensitivitiy(or history of hypersensitivity) to aspirin and clopidogrel
  • Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT, total bilirubin
  • Exceed the normal range of PT, aPTT, BT & platelet counts under 150,000/㎣ or exceed 350,000/㎣
  • Creatinine clearance < 80 mL/min
  • Gastrointestinal diseases or surgeries that affect absorption of drug
  • Congenital galactose intolerance, lactase deficiency and glucose-galactose malabsorption
  • Excessive drinking(exceed 21units/week)
  • Smoking over 10 cigarettes per day
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526122

Sponsors and Collaborators
Dong-A Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Young-ran Yoon, M.D., Ph.D. Kyungpook National University
  More Information

Publications:
Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01526122     History of Changes
Other Study ID Numbers: G0041(75/100mg)_AS_Ⅰ
Study First Received: January 11, 2012
Last Updated: February 1, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Dong-A Pharmaceutical Co., Ltd.:
Clopidogrel
Aspirin
coadministration

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists

ClinicalTrials.gov processed this record on April 17, 2014