NCT02010632

Brief Summary

The purpose of this study is to compare the pharmacodynamic effect of clopidogrel on the platelet inhibition and the pharmacokinetic profiles of clopidogrel carboxylic acid metabolite between generic and reference clopidogrel products in Thai healthy volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2013

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

August 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
5 months until next milestone

Results Posted

Study results publicly available

May 4, 2015

Completed
Last Updated

May 4, 2015

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

December 3, 2013

Results QC Date

March 30, 2015

Last Update Submit

April 16, 2015

Conditions

Pharmacodynamics

Keywords

ClopidogrelPlatelet inhibitionPlatelet aggregation

Outcome Measures

Primary Outcomes (1)

  • Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State)

    Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7

Secondary Outcomes (3)

  • Pharmacokinetic Profiles: Area Under the Concentration-Time Curve (AUC 0-24)

    Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7

  • Pharmacokinetic Profiles: The Maximum Plasma Concentration (Cmax)

    Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7

  • Pharmacokinetic Profiles: Time to Maximum Plasma Concentration (Tmax)

    Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7

Study Arms (2)

Generic clopidogrel product

EXPERIMENTAL

Apolets® 75 mg tablet

Drug: Generic clopidogrel product Apolets®

Original clopidogrel product

ACTIVE COMPARATOR

Plavix® 75mg tablet

Drug: Original clopidogrel product Plavix®

Interventions

Generic clopidogrel product Apolets®DRUG

* Clopidogrel 75 mg once daily for 7 days * Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7

Also known as: Apolets®
Generic clopidogrel product
Original clopidogrel product Plavix®DRUG

* Clopidogrel 75 mg once daily for 7 days * Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7

Also known as: Plavix®
Original clopidogrel product

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 45 years
  • Body mass index between 18-25 kg/m2
  • No clinically significant abnormalities, as confirmed on medical history; detailed physical examination; clinical laboratory analysis (blood hematology, biochemistry, prothrombin time, bleeding time, and urinalysis)

You may not qualify if:

  • An allergy to any drug; and/or a history of drug and/or alcohol abuse.
  • Subjects who had donated blood within 3 months prior to the start of this study or had participated in another investigational drug study within 3 months prior to the start of this study
  • Participating subjects were instructed to abstain from the use of any drugs for at least 2 weeks before and throughout the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Khon Kaen University

Khonkaen, Changwat Khon Kaen, 40000, Thailand

Location

MeSH Terms

Interventions

Clopidogrel

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Miss Nontaya Nakkam
Organization
Khon Kaen University
nonna_na@hotmail.com
66862642540

Study Officials

  • Wichittra Tassaneeyakul, Ph.D.

    Khon Kaen University

    PRINCIPAL INVESTIGATOR

  • Somsak Tiamkao, MD

    Khon Kaen University

    PRINCIPAL INVESTIGATOR

  • Sirimas Kanjanawart, Ph.D.

    Khon Kaen University

    PRINCIPAL INVESTIGATOR

  • Kutcharin Phunikhom, MD

    Khon Kaen University

    PRINCIPAL INVESTIGATOR

  • Nontaya Nakkam, B.Pharm

    Khon Kaen University

    PRINCIPAL INVESTIGATOR

  • Thanawat Kaewkamsorn, M.Sc.

    Khon Kaen University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr. Wichittra Tassaneeyakul, Departments of Pharmacology, Faculty of Medicine

Study Record Dates

First Submitted

December 3, 2013

First Posted

December 13, 2013

Study Start

August 1, 2013

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

May 4, 2015

Results First Posted

May 4, 2015

Record last verified: 2015-04

Locations

TH(1)