Skip to main content
OpenTrials
Completed

NCT Number: NCT01526122

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

G0041(75/100mg)

Drug

G0041(75/100mg) 2 capsules(Clopidogrel 75mg & Aspirin 100mg in 1 capsule), PO

Clopidogrel & Aspirin

Drug

Clopidogrel 75mg 2 tablets & Aspirin 100mg 2 capsules, PO

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 3, 2012
Registry last updated
Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.