NCT01448330

Brief Summary

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of clopidogrel and aspirin in free combination as HCP0911.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

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

July 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 7, 2011

Completed
Last Updated

December 30, 2011

Status Verified

September 1, 2011

Enrollment Period

2 months

First QC Date

September 27, 2011

Last Update Submit

December 28, 2011

Conditions

Healthy

Keywords

clopidogrelaspinincombination

Outcome Measures

Primary Outcomes (2)

  • Cmax

    0-24 hrs

  • AUC

    0-24 hrs

Study Arms (2)

HCP0911

EXPERIMENTAL

clopidogrel/aspirin combination tablet

Drug: HCP0911 / clopidogrel, aspirin

clopidorel and aspirin

ACTIVE COMPARATOR

coadministration of clopidogrel and aspirin

Drug: HCP0911 / clopidogrel, aspirin

Interventions

HCP0911 / clopidogrel, aspirinDRUG

combination tablet vs coadministration

HCP0911clopidorel and aspirin

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20 and 55
  • Signed informed consent

You may not qualify if:

  • Has a history of hypersensitivity to IP ingredients
  • Hypotension or hypertension
  • Has a history of acute infection within 14days of screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung medical center

Seoul, South Korea

Location

Related Publications (1)

  • Jung JA, Kim TE, Kim JR, Kim MJ, Huh W, Park KM, Lee SY, Ko JW. The pharmacokinetics and safety of a fixed-dose combination of acetylsalicylic acid and clopidogrel compared with the concurrent administration of acetylsalicylic acid and clopidogrel in healthy subjects: a randomized, open-label, 2-sequence, 2-period, single-dose crossover study. Clin Ther. 2013 Jul;35(7):985-94. doi: 10.1016/j.clinthera.2013.05.015.

    PMID: 23870608DERIVED

MeSH Terms

Interventions

ClopidogrelAspirin

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Jae-wook Ko, MD

    Samsung Medical Center

    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

September 27, 2011

First Posted

October 7, 2011

Study Start

July 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

December 30, 2011

Record last verified: 2011-09

Locations

KR(1)