PharmacodynamicsPhase 1NCT02010632
Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products
A Phase 1 study testing Generic clopidogrel product Apolets® and Original clopidogrel product Plavix® in people with Pharmacodynamics, run by Khon Kaen University at 1 site in Thailand.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacodynamics
- What is being tested?
- Generic clopidogrel product Apolets® and Original clopidogrel product Plavix®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2013to Dec 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Khon Kaen University
Khonkaen, Changwat Khon Kaen, 40000
About this study
Official title: Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products in Thai Healthy Volunteers
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
Read the detailed description
Platelet aggregation (ex vivo) were measured by using Whole blood impedence aggregometry (Chrono-log®) and VerifyNow® P2Y12 assay. Plasma concentration of clopidogrel carboxylic acid metabolite were measured by High performance liquid chromatography (HPLC).
- Conditions
- Pharmacodynamics
- Being tested
- Generic clopidogrel product Apolets®, Original clopidogrel product Plavix®
- Keywords
- Clopidogrel, Platelet inhibition, Platelet aggregation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generic clopidogrel product Apolets®Drug
Also called Apolets®
- 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
Original clopidogrel product Plavix®Drug
Also called Plavix®
- 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
| Study group | Role | What they receive |
|---|---|---|
| Generic clopidogrel product | Experimental | Apolets® 75 mg tablet Receives: Drug: Generic clopidogrel product Apolets® |
| Original clopidogrel product | Active comparator | Plavix® 75mg tablet Receives: Drug: Original clopidogrel product Plavix® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PharmacodynamicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wichittra Tassaneeyakul, Khon Kaen University
- Investigators
- Wichittra Tassaneeyakul, Ph.D., Principal investigator, Khon Kaen UniversitySomsak Tiamkao, MD, Principal investigator, Khon Kaen UniversitySirimas Kanjanawart, Ph.D., Principal investigator, Khon Kaen UniversityKutcharin Phunikhom, MD, Principal investigator, Khon Kaen UniversityNontaya Nakkam, B.Pharm, Principal investigator, Khon Kaen UniversityThanawat Kaewkamsorn, M.Sc., Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010632
- Sponsor's protocol ID
- PDPK-CLO-2013
- Status last verified
- Apr 2015
- First submitted
- 3 Dec 2013
- Last updated
- 4 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products in Thai Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02010632
- Acronym / sponsor ID
- PDPK-CLO-2013
- Conditions
- Pharmacodynamics
- Keywords
- Clopidogrel, Platelet inhibition, Platelet aggregation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Posted 4 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Platelet aggregation (ex vivo) were measured by using Whole blood impedence aggregometry (Chrono-log®) and VerifyNow® P2Y12 assay. Plasma concentration of clopidogrel carboxylic acid metabolite were measured by High performance liquid chromatography (HPLC).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generic clopidogrel product | Experimental | Drug: Generic clopidogrel product Apolets®Apolets® 75 mg tablet |
| Original clopidogrel product | Active comparator | Drug: Original clopidogrel product Plavix®Plavix® 75mg tablet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Generic clopidogrel product Apolets®Also: Apolets®* 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 | Drug | Generic clopidogrel product |
| Original clopidogrel product Plavix®Also: Plavix®* 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 | Drug | Original clopidogrel product |
Primary outcome
Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State)
Time frame: Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
3 secondary outcomes
Pharmacokinetic Profiles: Area Under the Concentration-Time Curve (AUC 0-24)
Time frame: 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)
Time frame: 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)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wichittra Tassaneeyakul, Ph.D. principal investigator
Khon Kaen University
Somsak Tiamkao, MD principal investigator
Khon Kaen University
Sirimas Kanjanawart, Ph.D. principal investigator
Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Generic clopidogrel product Apolets® and Original clopidogrel product Plavix® in people with Pharmacodynamics, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State) (time frame: Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.