HealthyPhase 1NCT02767310
Study to Determine the Bioequivalence of Two Products Containing Rosuvastatin (20 mg/Tablet)
A Phase 1 study testing Rosuvastatin 20 mg film-coated tablets and Crestor 20 mg film-coated tablets in people with Healthy, run by Verisfield UK Ltd. Greek Branch at 1 site in India.
Trial summary
The purpose of this study is to determine the bioequivalence of Rosuvastatin/ Verisfield 20 mg film-coated tablets and Crestor™/ AstraZeneca 20 mg film-coated tablets. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rosuvastatin 20 mg film-coated tablets and Crestor 20 mg film-coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteIndia
- Study dates
- May 2016to Jun 2016
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willingness to provide informed consent to participate in the study.
- Comprehension of the nature and purpose of the study and willingness to comply with the requirements of the entire procedure.
- Healthy adult, human Indian volunteers within the age range of 18 to 45 years (both inclusive).
- Body Mass Index (BMI) ≥ 18.50 kg/m2 to ≤ 30.00 kg/m2.
- Hemoglobin: ≥12.0 gm% for male and ≥11.5 gm% for female.
- Absence of disease markers of HIV I \& II, HBsAg, HCVAb and P24 antigen test.
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- Females of childbearing age must be practicing an acceptable form of birth control for at least six months before screening, unless they have had bilateral oophorectomy or tubal ligation or their male partner has had vasectomy.
- Females of childbearing age agree to use acceptable form of birth control during the study and until the drug is washed out from the body, i.e. at least 14 days after last dosing, unless they have had bilateral oophorectomy or tubal ligation or their male partner has had vasectomy.
- Absence of significant disease or clinically significant abnormal laboratory values during the laboratory evaluations.
- Absence of any diseases in medical history or physical examination during the screening.
- Have a normal 12-lead ECG or one with abnormality considered clinically insignificant.
- Have a normal chest X-ray (P. A. view).
- Non smokers (since last six months)
- Negative serum β-HCG at the time of screening (for females only)
Who cannot join
- History / evidence of allergy or hypersensitivity to rosuvastatin or to any of the excipients or to any other drug.
- Any major illness within the last three months or any significant ongoing chronic medical illness.
- History of or active liver or kidney disease.
- History of or active deep vein thrombosis and thromboembolic disorders.
- History of breast cancer, endometrial cancer or other estrogen-dependent neoplasia, endometriosis and undiagnosed vaginal bleeding (for females only).
- History of drug abuse (including barbiturates, benzodiazepines, opioids, cocaine, cannabinoids and amphetamine etc.) within the last three months.
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- History of neuropsychiatric diseases.
- History of hypothyroidism.
- Personal or family history of hereditary muscular disorders.
- History of myopathy.
- History of myalgia.
- History of rhabdomyolysis.
- History of alcohol abuse.
- History of proteinuria.
- Asian population (except Indian).
- History of interstitial lung disease.
- History of or current gastro-intestinal diseases influencing drug absorption.
- History of alcoholism (more than two years), moderate drinkers (more than three drinks per day).
- Participation in any clinical trial within last three months.
- History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm.
- Donation of blood (one unit or 350 mL or more) within last three months.
- Use of any prescription drug therapy within last two weeks and over the counter (OTC) drugs or herbal products within last one week.
- Pregnant women.
- Breast feeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pivotal, Open-label, Balanced, Randomised, Two-treatment, Two-sequence, Two-period, Two-way Crossover, Single Oral Dose Bioequivalence Study of Rosuvastatin/ Verisfield 20 mg Film-coated Tablets Versus Crestor/ AstraZeneca 20 mg Film-coated Tablets in Healthy Adults Under Fasting Conditions
The purpose of this study is to determine the bioequivalence of Rosuvastatin/ Verisfield 20 mg film-coated tablets and Crestor™/ AstraZeneca 20 mg film-coated tablets.
Read the detailed description
This study aims to compare the absorption and disposition kinetics of two products containing rosuvastatin under fasting conditions. These products are: Rosuvastatin/ Verisfield 20 mg film-coated tablets, a Test product manufactured by HELP S.A., Greece and Crestor™/ AstraZeneca 20 mg film-coated tablets, a Reference product manufactured by AstraZeneca, UK. The bioequivalence of a single 20 mg dose of both products will be assessed by comparing the pharmacokinetic parameters derived from the plasma concentration-time profiles for rosuvastatin.
- Conditions
- Healthy
- Being tested
- Rosuvastatin 20 mg film-coated tablets, Crestor 20 mg film-coated tablets
- Keywords
- Bioequivalence, two rosuvastatin-containing products
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 20 mg film-coated tabletsDrug
Single oral dose of 20 mg
Crestor 20 mg film-coated tabletsDrug
Single oral dose of 20 mg
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Rosuvastatin 20 mg film-coated tablets Receives: Drug: Rosuvastatin 20 mg film-coated tablets |
| Reference product | Active comparator | Crestor 20 mg film-coated tablets Receives: Drug: Crestor 20 mg film-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration (AUC0-t) from zero (0) hours to time (t)
The area under the plasma concentration versus time curve, from time zero (0) to t hours
Measured: Before dosing (0 hour) and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose
Maximum concentration (Cmax)
Maximum measured plasma concentration
Measured: Before dosing (0 hour) and 0.25, 0.50, 0.75, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose
Secondary outcomes (5)
Time to maximum concentration (Tmax)
Time of the maximum measured plasma concentration. If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value
Measured: Before dosing (0 hour) and 0.25, 0.50, 0.75, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose
Elimination rate constant (Kel)
Apparent first-order elimination or terminal rate constant
Measured: Before dosing (0 hour) and 0.25, 0.50, 0.75, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose
Terminal half life (t1/2)
The elimination or terminal half-life
Measured: Before dosing (0 hour) and 0.25, 0.50, 0.75, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose
Area under the plasma concentration (AUC0-infinity) from zero (0) hours to infinity
The area under the plasma concentration versus time curve from time (0) to infinity
Measured: Before dosing (0 hour) and 0.25, 0.50, 0.75, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose
Number of participants with Adverse Events
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verisfield UK Ltd. Greek Branch
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathiria Jayesh, M.D., Principal investigator, Synchron Research Services Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767310
- Sponsor's protocol ID
- ROS/2016/1278
- Status last verified
- May 2016
- First submitted
- 9 May 2016
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal, Open-label, Balanced, Randomised, Two-treatment, Two-sequence, Two-period, Two-way Crossover, Single Oral Dose Bioequivalence Study of Rosuvastatin/ Verisfield 20 mg Film-coated Tablets Versus Crestor/ AstraZeneca 20 mg Film-coated Tablets in Healthy Adults Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT02767310
- Acronym / sponsor ID
- ROS/2016/1278
- Conditions
- Healthy
- Keywords
- Bioequivalence, two rosuvastatin-containing products
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Verisfield UK Ltd. Greek BranchIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 May 2016 (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.
The purpose of this study is to determine the bioequivalence of Rosuvastatin/ Verisfield 20 mg film-coated tablets and Crestor™/ AstraZeneca 20 mg film-coated tablets.
Detailed description
This study aims to compare the absorption and disposition kinetics of two products containing rosuvastatin under fasting conditions. These products are: Rosuvastatin/ Verisfield 20 mg film-coated tablets, a Test product manufactured by HELP S.A., Greece and Crestor™/ AstraZeneca 20 mg film-coated tablets, a Reference product manufactured by AstraZeneca, UK. The bioequivalence of a single 20 mg dose of both products will be assessed by comparing the pharmacokinetic parameters derived from the plasma concentration-time profiles for rosuvastatin.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Drug: Rosuvastatin 20 mg film-coated tabletsRosuvastatin 20 mg film-coated tablets |
| Reference product | Active comparator | Drug: Crestor 20 mg film-coated tabletsCrestor 20 mg film-coated tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Willingness to provide informed consent to participate in the study.
- Comprehension of the nature and purpose of the study and willingness to comply with the requirements of the entire procedure.
- Healthy adult, human Indian volunteers within the age range of 18 to 45 years (both inclusive).
- Body Mass Index (BMI) ≥ 18.50 kg/m2 to ≤ 30.00 kg/m2.
- Hemoglobin: ≥12.0 gm% for male and ≥11.5 gm% for female.
Key exclusion criteria (24 listed)
- History / evidence of allergy or hypersensitivity to rosuvastatin or to any of the excipients or to any other drug.
- Any major illness within the last three months or any significant ongoing chronic medical illness.
- History of or active liver or kidney disease.
- History of or active deep vein thrombosis and thromboembolic disorders.
- History of breast cancer, endometrial cancer or other estrogen-dependent neoplasia, endometriosis and undiagnosed vaginal bleeding (for females only).
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 |
|---|---|---|
| Rosuvastatin 20 mg film-coated tabletsSingle oral dose of 20 mg | Drug | Test Product |
| Crestor 20 mg film-coated tabletsSingle oral dose of 20 mg | Drug | Reference product |
Primary outcome
Area under the plasma concentration (AUC0-t) from zero (0) hours to time (t)
Time frame: Before dosing (0 hour) and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose
The area under the plasma concentration versus time curve, from time zero (0) to t hours
Maximum concentration (Cmax)
Time frame: Before dosing (0 hour) and 0.25, 0.50, 0.75, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose
Maximum measured plasma concentration
5 secondary outcomes
Time to maximum concentration (Tmax)
Time frame: Before dosing (0 hour) and 0.25, 0.50, 0.75, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose
Elimination rate constant (Kel)
Time frame: Before dosing (0 hour) and 0.25, 0.50, 0.75, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose
Terminal half life (t1/2)
Time frame: Before dosing (0 hour) and 0.25, 0.50, 0.75, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose
Area under the plasma concentration (AUC0-infinity) from zero (0) hours to infinity
Time frame: Before dosing (0 hour) and 0.25, 0.50, 0.75, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose
Number of participants with Adverse Events
Time frame: 6 days
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 6 Jul 2016.
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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.
Kathiria Jayesh, M.D. principal investigator
Synchron Research Services Pvt. Ltd.
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 Rosuvastatin 20 mg film-coated tablets and Crestor 20 mg film-coated tablets in people with Healthy, run by Verisfield UK Ltd. Greek Branch 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 14 inclusion and 24 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 6 Jul 2016. 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?
Area under the plasma concentration (AUC0-t) from zero (0) hours to time (t) (time frame: Before dosing (0 hour) and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 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 6 Jul 2016.