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Study to Determine the Bioequivalence of Two Products Containing Rosuvastatin (20 mg/Tablet)

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ClinicalTrials.gov Identifier: NCT02767310
Recruitment Status : Completed
First Posted : May 10, 2016
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
Verisfield UK Ltd. Greek Branch

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Rosuvastatin 20 mg film-coated tablets Drug: Crestor 20 mg film-coated tablets Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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
Study Start Date : May 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test Product
Rosuvastatin 20 mg film-coated tablets
Drug: Rosuvastatin 20 mg film-coated tablets
Single oral dose of 20 mg

Active Comparator: Reference product
Crestor 20 mg film-coated tablets
Drug: Crestor 20 mg film-coated tablets
Single oral dose of 20 mg




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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 ]
    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

  2. 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 ]
    Apparent first-order elimination or terminal rate constant

  3. 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 ]
    The elimination or terminal half-life

  4. 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 ]
    The area under the plasma concentration versus time curve from time (0) to infinity

  5. Number of participants with Adverse Events [ Time Frame: 6 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.
  • 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)

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02767310


Locations
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India
Synchron Research Services Pvt. Ltd.
Ahmedabad, Gujarat, India, 380056
Sponsors and Collaborators
Verisfield UK Ltd. Greek Branch
Investigators
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Principal Investigator: Kathiria Jayesh, M.D. Synchron Research Services Pvt. Ltd.

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Responsible Party: Verisfield UK Ltd. Greek Branch
ClinicalTrials.gov Identifier: NCT02767310    
Other Study ID Numbers: ROS/2016/1278
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: May 2016
Keywords provided by Verisfield UK Ltd. Greek Branch:
Bioequivalence
two rosuvastatin-containing products
Additional relevant MeSH terms:
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Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors