NCT01526122

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
Last Updated

October 1, 2014

Status Verified

September 1, 2014

Enrollment Period

3 months

First QC Date

January 11, 2012

Last Update Submit

September 29, 2014

Conditions

Atherosclerosis

Keywords

ClopidogrelAspirincoadministration

Outcome Measures

Primary Outcomes (4)

  • C(max) of Clopidogrel

    0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h

  • AUC(last) of Clopidogrel

    0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h

  • C(max) of Acetylsalicylic acid

    0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h

  • AUC(last) of Acetylsalicylic acid

    0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h

Secondary Outcomes (2)

  • C(max) of Salicylic acid

    0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h

  • AUC(last) of Salicylic acid

    0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h

Study Arms (2)

G0041(75/100mg)

EXPERIMENTAL
Drug: G0041(75/100mg)

Clopidogrel & Aspirin

ACTIVE COMPARATOR
Drug: Clopidogrel & Aspirin

Interventions

G0041(75/100mg)DRUG

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

G0041(75/100mg)
Clopidogrel & AspirinDRUG

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

Clopidogrel & Aspirin

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Di Girolamo G, Czerniuk P, Bertuola R, Keller GA. Bioequivalence of two tablet formulations of clopidogrel in healthy Argentinian volunteers: a single-dose, randomized-sequence, open-label crossover study. Clin Ther. 2010 Jan;32(1):161-70. doi: 10.1016/j.clinthera.2010.01.010.

    PMID: 20171421BACKGROUND

  • Bae SK, Seo KA, Jung EJ, Kim HS, Yeo CW, Shon JH, Park KM, Liu KH, Shin JG. Determination of acetylsalicylic acid and its major metabolite, salicylic acid, in human plasma using liquid chromatography-tandem mass spectrometry: application to pharmacokinetic study of Astrix in Korean healthy volunteers. Biomed Chromatogr. 2008 Jun;22(6):590-5. doi: 10.1002/bmc.973.

    PMID: 18254152BACKGROUND

  • Kim SD, Kang W, Lee HW, Park DJ, Ahn JH, Kim MJ, Kim EY, Kim SW, Nam HS, Na HJ, Yoon YR. Bioequivalence and tolerability of two clopidogrel salt preparations, besylate and bisulfate: a randomized, open-label, crossover study in healthy Korean male subjects. Clin Ther. 2009 Apr;31(4):793-803. doi: 10.1016/j.clinthera.2009.04.017.

    PMID: 19446152BACKGROUND

  • EMEA(2009), CHMP assessment report of DuoCover. EMEA/H/C/001144

    BACKGROUND

MeSH Terms

Conditions

Atherosclerosis

Interventions

ClopidogrelAspirin

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Young-ran Yoon, M.D., Ph.D.

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2012

First Posted

February 3, 2012

Study Start

September 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 1, 2014

Record last verified: 2014-09