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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 9, 2016
First Posted Date  ICMJE May 10, 2016
Last Update Posted Date July 6, 2016
Study Start Date  ICMJE May 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2016)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2016)
  • 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
  • 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
  • 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
  • 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
  • Number of participants with Adverse Events [ Time Frame: 6 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Determine the Bioequivalence of Two Products Containing Rosuvastatin (20 mg/Tablet)
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Rosuvastatin 20 mg film-coated tablets
    Single oral dose of 20 mg
  • Drug: Crestor 20 mg film-coated tablets
    Single oral dose of 20 mg
Study Arms  ICMJE
  • Experimental: Test Product
    Rosuvastatin 20 mg film-coated tablets
    Intervention: Drug: Rosuvastatin 20 mg film-coated tablets
  • Active Comparator: Reference product
    Crestor 20 mg film-coated tablets
    Intervention: Drug: Crestor 20 mg film-coated tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2016)
49
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2016)
48
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02767310
Other Study ID Numbers  ICMJE ROS/2016/1278
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Verisfield UK Ltd. Greek Branch
Study Sponsor  ICMJE Verisfield UK Ltd. Greek Branch
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kathiria Jayesh, M.D. Synchron Research Services Pvt. Ltd.
PRS Account Verisfield UK Ltd. Greek Branch
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP