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HealthyPhase 1NCT01512485

Bioequivalence Study of Clopidogrel Tablets 75 mg Under Fed Conditions

A Phase 1 study testing Clopidogrel in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in Canada.

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

The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Laboratories Ltd, clopidogrel and Bristol-Myers Squibb Company, USA Plavix®, clopidogrel 75 mg tablet under fed condition. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Clopidogrel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteCanada
Study dates
Oct 2006to Oct 2006
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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may use various media types (e.g. radio, newspaper, Anapharm Web site, Anapharm volunteers' database). Subjects must meet all of the following criteria to be included in the study:
  • Male or female, non-smoker, ≥18 and ≤55 years of age.
  • Medically healthy with clinically normal laboratory profile, vital signs and ECG.
  • Capable of consent.
  • BMI ≥19.0 and <30.0

Who cannot join

  • Subjects to whom any of the following applies will be excluded from the study:
  • Clinically significant illness or surgery within 4 weeks prior to dosing.
  • Any clinically significant abnormality or abnormal laboratory test results found during medical screening.
  • Any reason which, in the opinion of the Clinical Sub-.investigator, would prevent the subject from participating in the study.
  • Positive test for hepatitis B, hepatitis C, or HIV at screening.
  • ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or• heart rate less than 50 or over J00 bpm) at screening.
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  • History of significant alcohol abuse or drug abuse within one year prior to the screening visit.
  • Regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [J Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]), or positive alcohol breath test at screening.
  • Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine (PCP] and -crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
  • History of allergic reactions to clopidogrel or other related drugs.
  • Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fIuoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
  • Use of an investigational drug or participation in an investigational study within 30 days prior to dosing.
  • Clinically significant history or presence of any gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
  • Any clinically significant history or presence of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, or metabolic disease.
  • Use of prescription medication within 14 days prior to administration of study medication or over-the counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption and hormonal contraceptives.
  • Difficulty to swallow study medication.
  • Use of any tobacco products in the 3 months preceding drug administration.
  • Any food allergy, intolerance, restriction or special diet that, in the opinion of the Clinical Sub-Investigator, could contraindicate the subject's participation in this study.
  • A depot injection or an implant of any drug (other than hormonal contraceptives) within 3 months prior to administration of study medication.
  • Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:
  • 50 mL to 499 mL of whole blood within 30 days,
  • more than 499 mL of whole blood within 56 days prior to drug administration.
  • Positive urine pregnancy test at screening.
  • Breast-feeding subject.
  • Female subjects of childbearing potential having unprotected sexual intercourse with any non-sterile male partner (i.e. male who has not been sterilized by vasectomy for at least 6 months) within 14 days prior to study drug administration. Acceptable methods of contraception are:
  • intra-uterine contraceptive device (placed at least 4 weeks prior to study drug administration;
  • condom or diaphragm + spermicide;
  • hormonal contraceptives (starting at least 4 weeks prior to study drug administration).
  • History or known active pathological bleeding (e.g. peptic ulcer, intracranial hemorrhage).
  • Increased risks of bleeding (e.g. frequent nose bleeding, recent trauma, surgery or other pathological condition).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Anapharm

    Sainte-Foy (Quebec)

Other trials in Canada

About this study

Official title: Randomized, Open-label, 2-Way Crossover, Bioequivalence Study of Clopidogrel 75 mg Tablet With Plavix® 75 mg In Healthy Subjects Under Fed Conditions

The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Laboratories Ltd, clopidogrel and Bristol-Myers Squibb Company, USA Plavix®, clopidogrel 75 mg tablet under fed condition.

Read the detailed description

Randomized, Open-label, 2-Way Crossover, Bioequivalence Study of Clopidogrel 75 mg Tablet (Dr. Reddy's Laboratories Ltd., India) and Plavix® (Bristol-Myers Squibb Company, USA) Following a 75 mg Dose In Healthy Subjects Under Fed Conditions.

Conditions
Healthy
Being tested
Clopidogrel
Keywords
Bioequivalence, Clopidogrel, crossover

What participants receive

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

  • ClopidogrelDrug

    Also called Plavix

    Clopidogrel Tablets 75 mg

Study groups in NCT01512485
Study groupRoleWhat they receive
ClopidogrelExperimentalClopidogrel tablets 75 mg of Dr. Reddy's Laboratories Limited
Receives: Drug: Clopidogrel
PlavixActive comparatorClopidogrel Tablet 75 mg
Receives: Drug: Clopidogrel

What is being measured

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

  1. Area Under Curve (AUC)

    Measured: predose, 0.250, 0.500, 0.750, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.0, 16.0, and 24.0 hours post-dose

Timeline

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

  1. First posted19 Jan 2012 (estimated)
  2. Study startOct 2006
  3. Primary completionOct 2006
  4. Study completionOct 2006

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01512485
Sponsor's protocol ID
60281
Status last verified
Jan 2012
First submitted
10 Jan 2012
Last updated
19 Jan 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Clopidogrel in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in Canada.

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 5 inclusion and 30 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 19 Jan 2012. 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 Canada. 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?

Area Under Curve (AUC) (time frame: predose, 0.250, 0.500, 0.750, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.0, 16.0, and 24.0 hours post-dose). 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 NCT01512485.

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 19 Jan 2012.

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