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

NCT02767310 | Completed Phase 1

• 1 other identifier: ROS/2016/1278
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioequivalence; two rosuvastatin-containing products

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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)

  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)

  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)

  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

  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

  6 days

Study Arms (2)

Test Product

EXPERIMENTAL

Rosuvastatin 20 mg film-coated tablets

Drug: Rosuvastatin 20 mg film-coated tablets

Reference product

ACTIVE COMPARATOR

Crestor 20 mg film-coated tablets

Drug: Crestor 20 mg film-coated tablets

Interventions

Rosuvastatin 20 mg film-coated tablets DRUG

Single oral dose of 20 mg

Test Product

Crestor 20 mg film-coated tablets DRUG

Single oral dose of 20 mg

Reference product

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Verisfield UK Ltd. Greek Branch: lead

Study Sites (1)

Synchron Research Services Pvt. Ltd.

Ahmedabad, Gujarat, 380056, India

Location

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kathiria Jayesh, M.D.

  Synchron Research Services Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 10, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 6, 2016

Record last verified: 2016-05

Locations

IN (1)