BioequivalencePhase 1NCT05186129
Bioequivalence Study of Clopid® (Clopidogrel) 75 mg Tablet and Plavix® 75 mg Tablet After Oral Administration to Healthy Adult Subjects Under Fasting Condition
A Phase 1 study testing Clopid® 75 mg Tablet and Plavix® 75mg Tablet in people with Bioequivalence, run by Center for Bioequivalence Studies and Clinical Research at 1 site in Pakistan.
Trial summary
To compare the rate and extent of absorption of Clopid® (Clopidogrel) 75 mg Tablet and Plavix® (clopidogrel) 75 mg tablet under fasting condition. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Clopid® 75 mg Tablet and Plavix® 75mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Apr 2018to 20 Apr 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects , age between 18 to 55 years old
- Body mass index (BMI) between 18.5-30.0 kg /m2.
- Subject is willing to participate and to Sign written informed consent form
- Subjects should have a blood pressure after resting for at least three minutes between 100-139 mmHg (systolic) and 60-89 mmHg (diastolic).
- Subjects should have a supine (ECG) heart rate between 60 and 100 beats/min after resting for at least 3 minutes.
- Ability to fast for 10 hours and consume standard meal.
- Subjects must be in good health as determined by medical history, physical exmination, ECG, vital signs, medical tests including biochemistry, urinalysis, serology and hematology in serum/urine.
Who cannot join
- • History of smoking , alcoholism, and a positive test for drugs of abuse, heavy pan or gutka user as judged by teeth / mouth inspection.
- Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication.
- Subjects allergic to Clopidogrel and/or, subjects who received any investigational drug within four weeks prior to screening.
- Intake of Smokeless tobacco, Tea, Coffee or other xanthenes derivatives (e.g. chocolate, cocoa) and poppy seeds 48 hours prior to study Check- In and must not consume grape fruit or juice of grape fruit at least 14 days prior to study.
- Donation or loss of more than 450 mL of blood within 3 months prior to the screening.
- Ingestion of OTC drug, within 14 days of drug administration (e.g. aspirin, ibuprofen)
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- History of intake of any prescribed medicine during a period of 30 days, prior to drug administration day of study.
- Other prescription medication such as Antidepressent (Bupripion), CYP2C19 inhibitors (cimetidine, esomeprazole, etravirine, felbamate, fluconazole, fluoxetine, fluvoxamine, ketoconazole, omeprazole, ticlopidine, voriconazole), Macrolide and related antibiotics (erythromycin, telithromycin), Proton pump inhibitors (esomeprazole, omeprazole), Rifamycins (rifampin) and Anti-Coagluant (Warfarin) should also not be taken before 14 days.
- Individuals who had undergone any major surgery within 3 months prior to the start of the study, unless deemed eligible by the Principal Investigator or whomever he/she may designate.
- Subject has a history of any illness that, in the opinion of investigator might confound the result of the study or post additional risk in administrating Clopidogrel to the subject.
- Subjects having any external wound.
- Inability to take oral medication.
- Subjects with clinically significant abnormalities in investigations (safety assessments) as determined by the Investigator.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Center for Bioequivalence Studies and Clinical Research (CBSCR) ICCBS, University of Karachi
Karachi, Sindh, 75270
About this study
Official title: To Determine the Bioequivalence of Clopid® (Clopidogrel) 75 mg Tablet Manufactured by Ferozsons Laboratories Ltd. Pakistan and Plavix® 75 mg Tablet Manufactured by Sanofi Winthrop Industrie France for Sanofi Pakistan After Oral Administration to Healthy Adult Male Subjects Under Fasting Condition
To compare the rate and extent of absorption of Clopid® (Clopidogrel) 75 mg Tablet and Plavix® (clopidogrel) 75 mg tablet under fasting condition.
Read the detailed description
Single dose, Randomized, Open-label, 2-Way Crossover, Bioequivalence Study of Clopid® of Ferozsons Laboratories Limited and Plavix® of Sanofi Winthrop Industrie France for Sanofi Pakistan Following a 75 mg Dose In Healthy Subjects Under Fasting Condition.
- Conditions
- Bioequivalence
- Being tested
- Clopid® 75 mg Tablet, Plavix® 75mg Tablet
- Keywords
- Clopidogrel, Platelet Aggregation Inhibitor, Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopid® 75 mg TabletDrug
Also called Clopidogrel
Single dose of Clopid® 75 mg Tablet (Clopidogrel) was administered after a 10-hour overnight fast.
Plavix® 75mg TabletDrug
Also called Clopidogrel
Single dose of Plavix® 75 mg Tablet (Clopidogrel) was administered after a 10-hour overnight fast.
| Study group | Role | What they receive |
|---|---|---|
| Clopid® 75 mg(Clopidogrel)Tablet of Ferozsons Laboratories Ltd. Pakistan | Experimental | Single dose of Clopid® 75 mg Tablet administered under fasting condition Receives: Drug: Clopid® 75 mg Tablet |
| Plavix® 75mg Tablet of Sanofi Winthrop Industrie France for Sanofi Pakistan. | Active comparator | Single dose of Plavix® 75 mg Tablet administered under fasting condition Receives: Drug: Plavix® 75mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
maximum plasma concentration
Measured: 0-36 hours post dose
AUC
Area under plasma concentration time curve
Measured: 0-36 hours post dose
Secondary outcomes (3)
Tmax
time to reach maximum plasma concentration
Measured: 0-36 hours post dose
t 1/2
Terminal half-life
Measured: 0-36 hours post dose
Incidence of Treatment-Emergent Adverse Event
safety and tolerability of Experimental drug Clopid® (Clopidogrel) 75 mg Tablet and Comparator drug Plavix® 75mg Tablet in Pakistani population
Measured: 0-36 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start6 Apr 2018
- Primary completion15 Apr 2018
- Study completion20 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Model description
- open label, randomized, single-dose, 2 way cross-over study
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Bioequivalence Studies and Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Ferozsons Laboratories Ltd.
- Responsible party
- Principal investigator, Dr. Naghma Hashmi, Center for Bioequivalence Studies and Clinical Research
- Investigators
- Dr. Muhammad R Raza, PhD, Principal investigator, Center for Bioequivalence Studies and Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186129
- Sponsor's protocol ID
- CB-024-CLO-2017/Protocol/1.0
- Status last verified
- Feb 2022
- First submitted
- 16 Dec 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study related information can be obtained via proper request to the Co-PI/PI unless the confidentiality of the participants are not compromised
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine the Bioequivalence of Clopid® (Clopidogrel) 75 mg Tablet Manufactured by Ferozsons Laboratories Ltd. Pakistan and Plavix® 75 mg Tablet Manufactured by Sanofi Winthrop Industrie France for Sanofi Pakistan After Oral Administration to Healthy Adult Male Subjects Under Fasting Condition
- ClinicalTrials.gov ID
- NCT05186129
- Acronym / sponsor ID
- CB-024-CLO-2017/Protocol/1.0
- Conditions
- Bioequivalence
- Keywords
- Clopidogrel, Platelet Aggregation Inhibitor, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Center for Bioequivalence Studies and Clinical ResearchUniversity, hospital or other
- Collaborators
- Ferozsons Laboratories Ltd.
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 11 Jan 2022 (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.
To compare the rate and extent of absorption of Clopid® (Clopidogrel) 75 mg Tablet and Plavix® (clopidogrel) 75 mg tablet under fasting condition.
Detailed description
Single dose, Randomized, Open-label, 2-Way Crossover, Bioequivalence Study of Clopid® of Ferozsons Laboratories Limited and Plavix® of Sanofi Winthrop Industrie France for Sanofi Pakistan Following a 75 mg Dose In Healthy Subjects Under Fasting Condition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label, randomized, single-dose, 2 way cross-over study
| Arm | Type | Receives |
|---|---|---|
| Clopid® 75 mg(Clopidogrel)Tablet of Ferozsons Laboratories Ltd. Pakistan | Experimental | Drug: Clopid® 75 mg TabletSingle dose of Clopid® 75 mg Tablet administered under fasting condition |
| Plavix® 75mg Tablet of Sanofi Winthrop Industrie France for Sanofi Pakistan. | Active comparator | Drug: Plavix® 75mg TabletSingle dose of Plavix® 75 mg Tablet administered under fasting condition |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male subjects , age between 18 to 55 years old
- Body mass index (BMI) between 18.5-30.0 kg /m2.
- Subject is willing to participate and to Sign written informed consent form
- Subjects should have a blood pressure after resting for at least three minutes between 100-139 mmHg (systolic) and 60-89 mmHg (diastolic).
- Subjects should have a supine (ECG) heart rate between 60 and 100 beats/min after resting for at least 3 minutes.
Key exclusion criteria (13 listed)
- • History of smoking , alcoholism, and a positive test for drugs of abuse, heavy pan or gutka user as judged by teeth / mouth inspection.
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 |
|---|---|---|
| Clopid® 75 mg TabletAlso: ClopidogrelSingle dose of Clopid® 75 mg Tablet (Clopidogrel) was administered after a 10-hour overnight fast. | Drug | Clopid® 75 mg(Clopidogrel)Tablet of Ferozsons Laboratories Ltd. Pakistan |
| Plavix® 75mg TabletAlso: ClopidogrelSingle dose of Plavix® 75 mg Tablet (Clopidogrel) was administered after a 10-hour overnight fast. | Drug | Plavix® 75mg Tablet of Sanofi Winthrop Industrie France for Sanofi Pakistan. |
Primary outcome
Cmax
Time frame: 0-36 hours post dose
maximum plasma concentration
AUC
Time frame: 0-36 hours post dose
Area under plasma concentration time curve
3 secondary outcomes
Tmax
Time frame: 0-36 hours post dose
t 1/2
Time frame: 0-36 hours post dose
Incidence of Treatment-Emergent Adverse Event
Time frame: 0-36 hours post dose
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 2 Mar 2022.
- Individual participant dataSharing planned: Yes. The study related information can be obtained via proper request to the Co-PI/PI unless the confidentiality of the participants are not compromised
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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.
Dr. Muhammad R Raza, PhD principal investigator
Center for Bioequivalence Studies and Clinical Research
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 Clopid® 75 mg Tablet and Plavix® 75mg Tablet in people with Bioequivalence, run by Center for Bioequivalence Studies and Clinical Research at 1 site in Pakistan.
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 7 inclusion and 13 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 2 Mar 2022. 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 Pakistan. 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?
Cmax (time frame: 0-36 hours post dose). 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?
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 2 Mar 2022.