HypercholesterolaemiaPhase 1NCT01597700
Acotral® Versus Zetia® Ezetimibe Bioequivalance Study.
A Phase 1 study testing 10mg Ezetimibe and 10 mg Ezetimibe - wash out period in people with Hypercholesterolaemia, run by GlaxoSmithKline at 1 site in India.
Trial summary
Bioequivalence study comparing test Acotral® ezetimibe 10 mg tablet manufactured by Laboratorios Phoenix, with a reference comparator Zetia® ezetimibe 10 mg tablet of Merck/Schering-Plough Pharmaceuticals. The CRO Clinigene Bangalore, will conduct the study. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolaemia
- What is being tested?
- 10mg Ezetimibe and 10 mg Ezetimibe - wash out period
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteIndia
- Study dates
- 13 Jan 2012to 30 Jan 2012
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Literate healthy adult male human subjects within the age range of 18 to 45 years inclusive.
- Weight not less than 50 kg.
- Normal BMI [18.5 to 24.99 kg/m2 inclusive].
- Willingness to provide written informed consent to participate in the study and capable of giving written informed consent to participate in the study.
- Free of significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG, Chest X-ray [PA view].
- AST, ALT, alkaline phosphatase and bilirubin 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Absence of disease markers of HIV 1 and 2, Hepatitis B and C and Syphilis.
- ECG normal for morphology and measurements. QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
Who cannot join
- History or presence of significant: Cardiovascular, pulmonary, hepatic, renal, hematological, gastro-intestinal, endocrine, immunologic, dermatologic, neurological, psychiatric disease.
- History or presence of significant:
- Alcohol dependence, alcohol abuse during past one year.
- Drug abuse for the last one month and other illicit drugs for the last 6 months.
- Smoking of more than 5 cigarettes per day or consumption of other forms of tobacco containing products.
- Asthma, urticaria or other allergic type reactions after taking aspirin or any other drug.
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- Ulceration or history of gastric and / or duodenal ulcer.
- Jaundice in the past 6 months.
- Bleeding disorder.
- Allergy to the test drug or any drug chemically similar to the drug or to the excipients of the products under investigation.
- Donation of 500 mL blood within 08 weeks prior to receiving the first dose of study drug.
- Subjects who have participated in another clinical study in the past 3 months prior to commencement of this study.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study assessments or compromise subject safety.
- Any difficulty in accessibility of forearm veins for cannulation or blood sampling.
- Refuse to abstain from food for at least 10 h prior to drug administration and for at least 4 h after dose in each period.
- Refuse to abstain from fluid for at least 1 h prior to and until 1 h post each dose.
- Found positive in breath alcohol test done on the day of check-in and ambulatory visit.
- Found positive in urine test for drug of abuse done on the day of check-in.
- History of difficulty in swallowing tablet.
- Use of enzyme modifying drugs within 30 days prior to receiving the first dose of study medication.
- Other Eligibility Criteria Considerations
- To assess any potential impact on subject eligibility with regard to safety, the investigator must refer to the product data sheet for detailed information regarding warnings, precautions, contraindications, adverse events, and other significant data pertaining to the product being used in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A RANDOMIZED, BALANCED, OPEN LABEL, CROSSOVER, TWO PERIOD, TWO TREATMENT, TWO SEQUENCE, SINGLE DOSE, BIOEQUIVALENCE STUDY OF ACOTRAL® EZETIMIBE 10 MG TABLETS CONTAINING EZETIMIBE MANUFACTURED BY LABORATORIOS PHOENIX S.A.I.C.F, ARGENTINA AND ZETIA® EZETIMIBE 10 MG TABLETS OF MERCK/SCHERING - PLOUGH PHARMACEUTICALS, USA IN HEALTHY ADULT HUMAN MALE SUBJECTS UNDER FASTING CONDITION
Bioequivalence study comparing test Acotral® ezetimibe 10 mg tablet manufactured by Laboratorios Phoenix, with a reference comparator Zetia® ezetimibe 10 mg tablet of Merck/Schering-Plough Pharmaceuticals. The CRO Clinigene Bangalore, will conduct the study. Fifty two healthy adult subjects who have satisfied the inclusion and exclusion criteria and given their informed consent will be entered into the study. They will be fasted and receive one tablet by mouth in accordance with a randomisation list and blood samples will be taken at specified intervals over the ensuing 3 days. Between 14 and 21 days later, subjects will receive the opposite tablet and the clinical process repeated. Subjects will be continuously monitored while in the trial clinic and at ambulatory visits with regular measurements of vital signs and questioned for adverse events. Drug concentrations will be analysed and these results compared to ascertain bioequivalence by applying statistical methods to the pharmacokinetic data; this information and all safety data will be formally reported.
Read the detailed description
This is a randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose bioequivalence study comparing test Acotral® ezetimibe 10 mg tablet manufactured by Laboratorios Phoenix, Argentina with a reference comparator Zetia® ezetimibe 10 mg tablet of Merck/Schering-Plough Pharmaceuticals, USA. The CRO Clinigene International Ltd, Bangalore, India will conduct the study. Fifty two healthy male adult subjects who have satisfied the inclusion and exclusion criteria and given their written informed consent will be entered into the study. They will be fasted overnight and receive one tablet by mouth in accordance with a randomisation list and venous blood samples will be taken at specified intervals over the ensuing 3 days; meals and water ad libitum will be allowed. Between 14 and 21 days later, subjects will return to the clinic and follow the same procedure to receive the opposite tablet and the clinical process repeated. Subjects will be continuously safety monitored while in the trial clinic and at ambulatory visits with regular measurements of vital signs and questioned for adverse events in accordance with the trial clinic SOPs. Drug concentrations will be analysed and these results compared in accordance with the study protocol to ascertain bioequivalence by applying statistical methods to the pharmacokinetic data; this information and all safety data will be formally reported to GSK.
- Conditions
- Hypercholesterolaemia
- Being tested
- 10mg Ezetimibe, 10 mg Ezetimibe - wash out period
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10mg EzetimibeDrug
1 tablet taken by mouth
10 mg Ezetimibe - wash out periodDrug
1 tablet taken by mouth received after wash out period
| Study group | Role | What they receive |
|---|---|---|
| Acotral® ezetimibe 10mg | Experimental | Subjects will be fasted overnight and receive one tablet by mouth in accordance with a randomisation list and venous blood samples will be taken at specified intervals over the ensuing 3 day. Receives: Drug: 10mg Ezetimibe |
| Zetia® ezetimibe 10mg | Active comparator | Subjects will be fasted overnight and receive one tablet by mouth in accordance with a randomisation list and venous blood samples will be taken at specified intervals over the ensuing 3 days. Receives: Drug: 10 mg Ezetimibe - wash out period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in plasma ezetimibe concentrations in time after dosing
Liquid chromatography and mass spectrometry
Measured: At 0 time and up to 72 hours after last dose
Number of participants with adverse events
Safety monitoring
Measured: At 0 time and up to 72 hours after last dose
Number of participants with changes in haematology and/or chemistry
Measured: 21 to 0 days before first dose and 3 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study start13 Jan 2012
- Primary completion30 Jan 2012
- Study completion30 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolaemiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597700
- Sponsor's protocol ID
- 116051
- Status last verified
- Jun 2017
- First submitted
- 22 Mar 2012
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED, BALANCED, OPEN LABEL, CROSSOVER, TWO PERIOD, TWO TREATMENT, TWO SEQUENCE, SINGLE DOSE, BIOEQUIVALENCE STUDY OF ACOTRAL® EZETIMIBE 10 MG TABLETS CONTAINING EZETIMIBE MANUFACTURED BY LABORATORIOS PHOENIX S.A.I.C.F, ARGENTINA AND ZETIA® EZETIMIBE 10 MG TABLETS OF MERCK/SCHERING - PLOUGH PHARMACEUTICALS, USA IN HEALTHY ADULT HUMAN MALE SUBJECTS UNDER FASTING CONDITION
- ClinicalTrials.gov ID
- NCT01597700
- Acronym / sponsor ID
- 116051
- Conditions
- Hypercholesterolaemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2012 (actual)
- Primary completion
- 30 Jan 2012 (actual)
- Study completion
- 30 Jan 2012 (actual)
- First posted
- 14 May 2012 (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.
Bioequivalence study comparing test Acotral® ezetimibe 10 mg tablet manufactured by Laboratorios Phoenix, with a reference comparator Zetia® ezetimibe 10 mg tablet of Merck/Schering-Plough Pharmaceuticals. The CRO Clinigene Bangalore, will conduct the study. Fifty two healthy adult subjects who have satisfied the inclusion and exclusion criteria and given their informed consent will be entered into the study. They will be fasted and receive one tablet by mouth in accordance with a randomisation list and blood samples will be taken at specified intervals over the ensuing 3 days. Between 14 and 21 days later, subjects will receive the opposite tablet and the clinical process repeated. Subjects will be continuously monitored while in the trial clinic and at ambulatory visits with regular measurements of vital signs and questioned for adverse events. Drug concentrations will be analysed and these results compared to ascertain bioequivalence by applying statistical methods to the pharmacokinetic data; this information and all safety data will be formally reported.
Detailed description
This is a randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose bioequivalence study comparing test Acotral® ezetimibe 10 mg tablet manufactured by Laboratorios Phoenix, Argentina with a reference comparator Zetia® ezetimibe 10 mg tablet of Merck/Schering-Plough Pharmaceuticals, USA. The CRO Clinigene International Ltd, Bangalore, India will conduct the study. Fifty two healthy male adult subjects who have satisfied the inclusion and exclusion criteria and given their written informed consent will be entered into the study. They will be fasted overnight and receive one tablet by mouth in accordance with a randomisation list and venous blood samples will be taken at specified intervals over the ensuing 3 days; meals and water ad libitum will be allowed. Between 14 and 21 days later, subjects will return to the clinic and follow the same procedure to receive the opposite tablet and the clinical process repeated. Subjects will be continuously safety monitored while in the trial clinic and at ambulatory visits with regular measurements of vital signs and questioned for adverse events in accordance with the trial clinic SOPs. Drug concentrations will be analysed and these results compared in accordance with the study protocol to ascertain bioequivalence by applying statistical methods to the pharmacokinetic data; this information and all safety data will be formally reported to GSK.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acotral® ezetimibe 10mg | Experimental | Drug: 10mg EzetimibeSubjects will be fasted overnight and receive one tablet by mouth in accordance with a randomisation list and venous blood samples will be taken at specified intervals over the ensuing 3 day. |
| Zetia® ezetimibe 10mg | Active comparator | Drug: 10 mg Ezetimibe - wash out periodSubjects will be fasted overnight and receive one tablet by mouth in accordance with a randomisation list and venous blood samples will be taken at specified intervals over the ensuing 3 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Literate healthy adult male human subjects within the age range of 18 to 45 years inclusive.
- Weight not less than 50 kg.
- Normal BMI [18.5 to 24.99 kg/m2 inclusive].
- Willingness to provide written informed consent to participate in the study and capable of giving written informed consent to participate in the study.
- Free of significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG, Chest X-ray [PA view].
Key exclusion criteria (22 listed)
- History or presence of significant: Cardiovascular, pulmonary, hepatic, renal, hematological, gastro-intestinal, endocrine, immunologic, dermatologic, neurological, psychiatric disease.
- History or presence of significant:
- Alcohol dependence, alcohol abuse during past one year.
- Drug abuse for the last one month and other illicit drugs for the last 6 months.
- Smoking of more than 5 cigarettes per day or consumption of other forms of tobacco containing products.
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 |
|---|---|---|
| 10mg Ezetimibe1 tablet taken by mouth | Drug | Acotral® ezetimibe 10mg |
| 10 mg Ezetimibe - wash out period1 tablet taken by mouth received after wash out period | Drug | Zetia® ezetimibe 10mg |
Primary outcome
Changes from baseline in plasma ezetimibe concentrations in time after dosing
Time frame: At 0 time and up to 72 hours after last dose
Liquid chromatography and mass spectrometry
Number of participants with adverse events
Time frame: At 0 time and up to 72 hours after last dose
Safety monitoring
Number of participants with changes in haematology and/or chemistry
Time frame: 21 to 0 days before first dose and 3 days after last 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 20 Jun 2017.
- Results for study 116051 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 10mg Ezetimibe and 10 mg Ezetimibe - wash out period in people with Hypercholesterolaemia, run by GlaxoSmithKline at 1 site in India.
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 8 inclusion and 22 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 20 Jun 2017. 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 India. 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?
Changes from baseline in plasma ezetimibe concentrations in time after dosing (time frame: At 0 time and up to 72 hours after last dose). The study lists 3 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 20 Jun 2017.