PharmacokineticsPhase 1NCT05125549

Fasted Bioequivalence Study of Clopidogrel Film-coated Tablets, 75 mg in 48 Healthy, Adult Male and Female Subjects.

A Phase 1 study testing Сlopidogrel bisulfate film-coated tablets, 75 mg (JSC Farmak, Ukraine) and Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France) in people with Pharmacokinetics, run by Joint Stock Company "Farmak" at 1 site in Ukraine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study was designed to compare bioequivalence of the Test Product Clopidogrel bisulfate, film-coated tablets, 75 mg (JSC Farmak, Ukraine) and Reference Product Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France) in healthy male and female volunteers under fasting conditions. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Pharmacokinetics
What is being tested?: Сlopidogrel bisulfate film-coated tablets, 75 mg (JSC Farmak, Ukraine) and Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteUkraine
Study dates: 12 Jul 2018to 27 Aug 2018
Phase: Phase 1
Are there results?: None posted in the registry

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 50 years
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males and non-pregnant and no breast-feeding females1), ≥18 and ≤50 years of age (on the day of Informed Consent). Caucasian race.
Subject had provided his/her written informed consent before the start of any screening procedures.
Subject was available for the whole study and to follow all the requirements of the study protocol.
Body Mass Index (BMI) 18.5 to 30.0 kg/m2, inclusive (on the day of screening).
Subject without any acute or chronic diseases of the cardiovascular system, neuroendocrine system, kidney, liver, gastrointestinal tract, respiratory system.
Subjects in good health, as determined by screening medical history, physical examination, vital signs assessments (pulse rate, systolic and diastolic blood pressure, and body temperature) and 12-lead electrocardiogram (ECG). Minor deviations outside the reference ranges were acceptable, if deemed not clinically significant by the Investigator

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The results of fluorography are within normal ranges (no more than 10 months before inclusion in the study).
Sitting blood pressure is within normal ranges: 100 -140 mm Hg for systolic PB, 55 -95 mm Hg. for diastolic blood pressure (BP) at screening;
Acceptance of use of contraceptive measures during the whole study by both female and male subjects.
Non-smoker
Subject is available to comply with the general dietary restrictions throughout the study.

Who cannot join

History of severe allergy or allergic reactions to the study Investigational Medicinal Product (IMP), its excipients or related drugs.
Aggravated allergic history
History of any clinically significant disease or disorder or surgical intervention which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
A positive result of Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), and / or (human immunodeficiency virus) HIV or syphilis tests during screening procedure.
A positive results of urine drug of abuse test (amphetamine, methamphetamine, morphine, marijuana, cocaine).
Positive result of alcohol breath test

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Positive urine cotinine test
The values of the standard parameters of the laboratory and instrumental examinations are outside the normal range and are clinically relevant or require additional examination and interpretation.
Pregnancy (positive urine pregnancy test result in women)
Lactation period (for women).
Acute infectious diseases in less than 28 days before the first dosing.
Use of any medication for a period of 14 days before the first dosing.
Donation of blood within 30 days before the first dosing.
Participation in any other clinical study during last 90 days.
Other reasons when participation of a volunteer in the study is undesirable in the opinion of the Investigator.

Trial locations and contacts

1 site in 1 country.

Ukraine1 site

Clinical and Diagnostics Center of National University of Pharmacy (NUPh).
Kharkiv

Other trials in Ukraine

About this study

Official title: Fasting, Comparative, Open-label, Randomized, Four-period, Two-sequence, Bioequivalence Study of Сlopidogrel Bisulfate Film-coated Tablets, 75 mg (JSC Farmak, Ukraine) vs Plavix® 75 mg Film-coated Tablets in Healthy Adult Subjects

Read the detailed description

An open, comparative, randomized, four-period, two- sequence, two-way crossover clinical trial to evaluate the Bioequivalence of Single Doses of Test Product Clopidogrel bisulfate, film-coated tablets, 75 mg (JSC Farmak, Ukraine) and Reference Product Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France) in healthy adult male and female volunteers under fasting conditions.

Conditions: Pharmacokinetics
Being tested: Сlopidogrel bisulfate film-coated tablets, 75 mg (JSC Farmak, Ukraine), Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France)
Keywords: bioequivalence, pharmacokinetics, generic drugs, Clopidogrel, Film-coated Tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Сlopidogrel bisulfate film-coated tablets, 75 mg (JSC Farmak, Ukraine)Drug
Also called Trombonet
One film-coated tablet was administrated orally with 240 ml of water after an overnight fast
Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France)Drug
One film-coated tablet was administrated orally with 240 ml of water after an overnight fast

Study groups in NCT05125549
Study group	Role	What they receive
Treatment A	Experimental	Сlopidogrel bisulfate film-coated tablets, 75 mg (JSC Farmak, Ukraine) Receives: Drug: Сlopidogrel bisulfate film-coated tablets, 75 mg (JSC Farmak, Ukraine)
Treatment B	Active comparator	Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France) Receives: Drug: Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France)

What is being measured

The primary outcome is the main question the study is designed to answer.

Сmax
maximum plasma concentration observed
Measured: up to 36 hours post-administration
AUC0-t
area under the plasma concentration versus time curve calculated by the trapezoidal rule from sampling time zero to sampling time of the last measurable plasma concentration
Measured: up to 36 hours post-administration

Secondary outcomes (1)

tmax
the time of the maximum plasma drug concentration
Measured: up to 36 hours post-administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jul 201827 Aug 2018

First posted18 Nov 2021
Study start12 Jul 2018
Primary completion27 Aug 2018
Study completion27 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PharmacokineticsStudies 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
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05125549
Sponsor's protocol ID: FK-CLP
Status last verified: Nov 2021
First submitted: 16 Nov 2021
Last updated: 18 Nov 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pharmacokinetics trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fasting, Comparative, Open-label, Randomized, Four-period, Two-sequence, Bioequivalence Study of Сlopidogrel Bisulfate Film-coated Tablets, 75 mg (JSC Farmak, Ukraine) vs Plavix® 75 mg Film-coated Tablets in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT05125549
Acronym / sponsor ID: FK-CLP
Conditions: Pharmacokinetics
Keywords: bioequivalence, pharmacokinetics, generic drugs, Clopidogrel, Film-coated Tablets
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Joint Stock Company "Farmak"Industry (pharma, biotech, devices)
Study start: 12 Jul 2018 (actual)
Primary completion: 27 Aug 2018 (actual)
Study completion: 27 Aug 2018 (actual)
First posted: 18 Nov 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment A	Experimental	Drug: Сlopidogrel bisulfate film-coated tablets, 75 mg (JSC Farmak, Ukraine)Сlopidogrel bisulfate film-coated tablets, 75 mg (JSC Farmak, Ukraine)
Treatment B	Active comparator	Drug: Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France)Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France)

Who may qualify

Ages: 18 to 50 years
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Healthy males and non-pregnant and no breast-feeding females1), ≥18 and ≤50 years of age (on the day of Informed Consent). Caucasian race.
Subject had provided his/her written informed consent before the start of any screening procedures.
Subject was available for the whole study and to follow all the requirements of the study protocol.
Body Mass Index (BMI) 18.5 to 30.0 kg/m2, inclusive (on the day of screening).
Subject without any acute or chronic diseases of the cardiovascular system, neuroendocrine system, kidney, liver, gastrointestinal tract, respiratory system.

Key exclusion criteria (15 listed)

History of severe allergy or allergic reactions to the study Investigational Medicinal Product (IMP), its excipients or related drugs.
Aggravated allergic history
History of any clinically significant disease or disorder or surgical intervention which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
A positive result of Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), and / or (human immunodeficiency virus) HIV or syphilis tests during screening procedure.
A positive results of urine drug of abuse test (amphetamine, methamphetamine, morphine, marijuana, cocaine).

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
Сlopidogrel bisulfate film-coated tablets, 75 mg (JSC Farmak, Ukraine)Also: TrombonetOne film-coated tablet was administrated orally with 240 ml of water after an overnight fast	Drug	Treatment A
Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France)One film-coated tablet was administrated orally with 240 ml of water after an overnight fast	Drug	Treatment B

Primary outcome

Сmax
Time frame: up to 36 hours post-administration
maximum plasma concentration observed
AUC0-t
Time frame: up to 36 hours post-administration
area under the plasma concentration versus time curve calculated by the trapezoidal rule from sampling time zero to sampling time of the last measurable plasma concentration

1 secondary outcome

tmax
Time frame: up to 36 hours post-administration

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
Individual participant dataSharing planned: No

Related trials for Pharmacokinetics

RecruitingObservational study
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Pyelonephritis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingPhase 2
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Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
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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.

Vlad Udovytskyi study chair

Joint Stock Company "Farmak"

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 15 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 18 Nov 2021. 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 Ukraine. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Сmax (time frame: up to 36 hours post-administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05125549.

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 18 Nov 2021.