Comparative Bioavailability of Clopidogrel TabletsPhase 1NCT01447563
Comparative Bioavailability Study of Two Oral Formulations of Clopidogrel
A Phase 1 study testing Clopidogrel bisulfate and Clopidogrel in people with Comparative Bioavailability of Clopidogrel Tablets, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
Background: Clopidogrel, a potent inhibitor of adenosine diphosphate-induced platelet activation, is widely used to prevent and reduce the risk of thrombotic events. Objective: the aim of the present study is to evaluate the bioequivalence of two oral formulations of 75 mg clopidogrel tablets. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Comparative Bioavailability of Clopidogrel Tablets
- What is being tested?
- Clopidogrel bisulfate and Clopidogrel
- 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 siteMexico
- Study dates
- May 2008to Aug 2008
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female and age is between 18 and 40 years, inclusive.
- Females must have negative results for pregnancy tests performed:at Screening on a urine specimen obtained within 2 weeks prior to initial study drug administration, and prior to dosing on urine sample obtained on Study Day -1 of each period
- Body Mass Index (BMI) is 19 to 26, inclusive. BMI is calculated as weight in kg divided by the square of height measured in meters.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
- Must voluntarily sign and date each informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Who cannot join
- History of significant sensitivity to any drug.
- Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements, on a regular basis.
- Use of any medications, vitamins and/or herbal supplements, within the 1-week period prior to study drug administration.
- Pregnant or breastfeeding female.
- Recent (6-month) history of drug or alcohol abuse.
- Positive test result for hepatitis B surface antigen (HBsAg) or HIV antibodies (HIV Ab). Negative HIV status will be confirmed at Screening and the results will be maintained confidentially by the study site.
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- Use of known inhibitors (e.g., ketoconazole) or inducers (e.g., carbamazepine) of cytochrome P450 3A (CYP3A) within 1 month prior to study drug administration.
- Positive screen for drugs of abuse, or alcohol or nicotine or positive and clinically significant urine adulterants test.
- Receipt of any drug by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study drug administration.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
- Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration.
- Receipt of any investigational product within 8 weeks prior to study drug administration or 7 half-lives, whichever is longer.
- Consumption of alcohol within the 3-day period prior to study drug administration.
- Consumption of grapefruit or grapefruit products, Seville oranges, star fruit and quinine/tonic water from 3 days prior to study drug administration.
- Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.
- Current enrollment in another clinical study.
- Consideration by the investigator, for an reason, that the subject is an unsuitable candidate to receive Ibuprofen
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Departamento de Farmacologia y Toxicologia
Monterrey, Nuevo León, 64460
About this study
Official title: Bioavailability of Two Oral Formulations of Clopidogrel: A Randomized, Open Label, Single Dose, Two-Period, Crossover Comparison in Healthy Mexican Volunteers
Background: Clopidogrel, a potent inhibitor of adenosine diphosphate-induced platelet activation, is widely used to prevent and reduce the risk of thrombotic events. Objective: the aim of the present study is to evaluate the bioequivalence of two oral formulations of 75 mg clopidogrel tablets. Method: The study is an open, randomized, single-dose, two-period crossover trial conducted on 32 healthy Mexican volunteers in a fasted state. A single oral dose of the test or reference drug will be followed by a 7 day washout period, after which subjects will receive the alternative formulation. Blood samples were collected up to 24 h after dosing. In order to determine bioequivalence, the plasma concentrations of clopidogrel carboxylic acid metabolite was determined using high-performance liquid chromatography-tandem mass spectrometry area under the plasma concentration time curve from zero to the last quantifiable level (AUC0-t), area under the plasma concentration time curve extrapolated to infinity (AUC0-∞), maximum plasma concentration (Cmax), the plasma elimination half-life (Tmax) and plasma half-life (T1/2) were calculated for both formulations.
Read the detailed description
Study procedure In each period, the subjects arrived at the clinical/unit site on the day before the commencement of the study and were randomized using Excel® 2007 to receive the test formulation followed by the reference formulation, or viceversa. No food was allowed from 10 h before until at least 4 h after drug administration. On the subsequent morning, a peripheral venous 21G catheter was inserted in the antecubital vein of the subjects and blood samples were collected (zero time). The subjects then received a single 75 mg tablet of either the test or the reference formulation, given with 250 mL water. Blood samples were collected at 0.16, 0.33, 0.5, 0.66, 0.83, 1, 1.5, 1.75, 2, 2.5, 3, 6, 8, 12, 16 and 24 h after drug administration. The blood samples were collected in coded EDTA tubes and plasma was obtained by centrifugation (2,053 g for 10 min at 5 C), after which the plasma was immediately transferred to prelabeled vials and stored at or below -70 After a week of washout, the alternative formulation was administered to the subjects and samples were drawn and analyzed as before.
- Being tested
- Clopidogrel bisulfate, Clopidogrel
- Keywords
- Bioequivalence, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel bisulfateDrug
Also called Plavix
subjects received a single 75 mg tablet of the reference formulation, given with 250 mL water
ClopidogrelDrug
subjects received a single 75 mg tablet of the test formulation, given with 250 mL water
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel tablets 75mg | Experimental | subjects received a single 75 mg tablet of the reference formulation, given with 250 mL water Receives: Drug: Clopidogrel bisulfate |
| Clopidogrel | Experimental | subjects received a single 75 mg tablet of the test formulation, given with 250 mL water Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum plasma concentration (Cmax)
Measured: at 0.16, 0.33, 0.5, 0.66, 0.83, 1, 1.5, 1.75, 2, 2.5, 3, 6, 8, 12, 16 and 24 h after drug administration
Secondary outcomes (2)
area under the plasma concentration time curve from zero to the last quantifiable level (AUC0-t),
Measured: 0.16, 0.33, 0.5, 0.66, 0.83, 1, 1.5, 1.75, 2, 2.5, 3, 6, 8, 12, 16 and 24 h after drug administration
area under the plasma concentration time curve extrapolated to infinity (AUC0-∞)
Measured: at 0.16, 0.33, 0.5, 0.66, 0.83, 1, 1.5, 1.75, 2, 2.5, 3, 6, 8, 12, 16 and 24 h after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startMay 2008
- Primary completionJun 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparative Bioavailability of Clopidogrel TabletsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lourdes Garza Ocañas, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Lourdes Garza Ocañas, MD PhD, Principal investigator, Hospital Universitario Jose E Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447563
- Sponsor's protocol ID
- CLOPI Tabs No. 60-06
- Status last verified
- Oct 2011
- First submitted
- 4 Oct 2011
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Two Oral Formulations of Clopidogrel: A Randomized, Open Label, Single Dose, Two-Period, Crossover Comparison in Healthy Mexican Volunteers
- ClinicalTrials.gov ID
- NCT01447563
- Acronym / sponsor ID
- CLOPI Tabs No. 60-06
- Keywords
- Bioequivalence, Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 6 Oct 2011 (estimated)
- 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.
Background: Clopidogrel, a potent inhibitor of adenosine diphosphate-induced platelet activation, is widely used to prevent and reduce the risk of thrombotic events. Objective: the aim of the present study is to evaluate the bioequivalence of two oral formulations of 75 mg clopidogrel tablets. Method: The study is an open, randomized, single-dose, two-period crossover trial conducted on 32 healthy Mexican volunteers in a fasted state. A single oral dose of the test or reference drug will be followed by a 7 day washout period, after which subjects will receive the alternative formulation. Blood samples were collected up to 24 h after dosing. In order to determine bioequivalence, the plasma concentrations of clopidogrel carboxylic acid metabolite was determined using high-performance liquid chromatography-tandem mass spectrometry area under the plasma concentration time curve from zero to the last quantifiable level (AUC0-t), area under the plasma concentration time curve extrapolated to infinity (AUC0-∞), maximum plasma concentration (Cmax), the plasma elimination half-life (Tmax) and plasma half-life (T1/2) were calculated for both formulations.
Detailed description
Study procedure In each period, the subjects arrived at the clinical/unit site on the day before the commencement of the study and were randomized using Excel® 2007 to receive the test formulation followed by the reference formulation, or viceversa. No food was allowed from 10 h before until at least 4 h after drug administration. On the subsequent morning, a peripheral venous 21G catheter was inserted in the antecubital vein of the subjects and blood samples were collected (zero time). The subjects then received a single 75 mg tablet of either the test or the reference formulation, given with 250 mL water. Blood samples were collected at 0.16, 0.33, 0.5, 0.66, 0.83, 1, 1.5, 1.75, 2, 2.5, 3, 6, 8, 12, 16 and 24 h after drug administration. The blood samples were collected in coded EDTA tubes and plasma was obtained by centrifugation (2,053 g for 10 min at 5 C), after which the plasma was immediately transferred to prelabeled vials and stored at or below -70 After a week of washout, the alternative formulation was administered to the subjects and samples were drawn and analyzed as before.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel tablets 75mg | Experimental | Drug: Clopidogrel bisulfatesubjects received a single 75 mg tablet of the reference formulation, given with 250 mL water |
| Clopidogrel | Experimental | Drug: Clopidogrelsubjects received a single 75 mg tablet of the test formulation, given with 250 mL water |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female and age is between 18 and 40 years, inclusive.
- Females must have negative results for pregnancy tests performed:at Screening on a urine specimen obtained within 2 weeks prior to initial study drug administration, and prior to dosing on urine sample obtained on Study Day -1 of each period
- Body Mass Index (BMI) is 19 to 26, inclusive. BMI is calculated as weight in kg divided by the square of height measured in meters.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
- Must voluntarily sign and date each informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Key exclusion criteria (18 listed)
- History of significant sensitivity to any drug.
- Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements, on a regular basis.
- Use of any medications, vitamins and/or herbal supplements, within the 1-week period prior to study drug administration.
- Pregnant or breastfeeding female.
- Recent (6-month) history of drug or alcohol abuse.
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 |
|---|---|---|
| Clopidogrel bisulfateAlso: Plavixsubjects received a single 75 mg tablet of the reference formulation, given with 250 mL water | Drug | Clopidogrel tablets 75mg |
| Clopidogrelsubjects received a single 75 mg tablet of the test formulation, given with 250 mL water | Drug | Clopidogrel |
Primary outcome
maximum plasma concentration (Cmax)
Time frame: at 0.16, 0.33, 0.5, 0.66, 0.83, 1, 1.5, 1.75, 2, 2.5, 3, 6, 8, 12, 16 and 24 h after drug administration
2 secondary outcomes
area under the plasma concentration time curve from zero to the last quantifiable level (AUC0-t),
Time frame: 0.16, 0.33, 0.5, 0.66, 0.83, 1, 1.5, 1.75, 2, 2.5, 3, 6, 8, 12, 16 and 24 h after drug administration
area under the plasma concentration time curve extrapolated to infinity (AUC0-∞)
Time frame: at 0.16, 0.33, 0.5, 0.66, 0.83, 1, 1.5, 1.75, 2, 2.5, 3, 6, 8, 12, 16 and 24 h after drug administration
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
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.
Lourdes Garza Ocañas, MD PhD principal investigator
Hospital Universitario Jose E Gonzalez
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 Clopidogrel bisulfate and Clopidogrel in people with Comparative Bioavailability of Clopidogrel Tablets, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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 18 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: stopped early, as of the sponsor's last update on 6 Oct 2011. 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 Mexico. 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 was stopped early. Results are not available in the source record.
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?
maximum plasma concentration (Cmax) (time frame: at 0.16, 0.33, 0.5, 0.66, 0.83, 1, 1.5, 1.75, 2, 2.5, 3, 6, 8, 12, 16 and 24 h after drug administration). 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 6 Oct 2011.