Rosuvastatin Calcium Bioequivalence Study - Fast

NCT01711749 | Completed Phase 1

• 1 other identifier: 117120
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, randomized, two treatment, two sequences, two periods crossover study, using a crossover 2x2 design, where each subject will be randomly assigned to reference or test formulation, in order to evaluate if both formulations are bioequivalent.

Conditions

Hypercholesterolaemia

Outcome Measures

Primary Outcomes (5)

• Area Under the Curve 0-t (AUC)

  Drug concentration area under the curve versus time, calculated by trapezoidal methods of time 0 to time t, where t is the time related to the last drug concentration, experimentally determined above the Quantification Limit (QL).

  Collections points from time 0 to 72 hours after the drug administration, evaluated in two periods.

• Area Under the Curve 0-infinite (AUC)

  Drug concentration area under the curve versus time, (time 0) infinite-extrapolated, where AUC\[0-infinite\] = AUC\[0-t\] + Ct/k, where Ct is the last drug concentration, experimentally determined (above the quantification limit) in that k is the terminal phase clearance constant.

  Collections points from time 0 to 72 hours after the drug administration, evaluated in two periods.

• Half Life (T1/2)

  Half life is calculated as ln(2) / k

  Collections points from time 0 to 72 hours after the drug administration, evaluated in two periods.

• Maximum concentration (Cmax)

  Maximum concentration reached after drug administration

  Collections points from time 0 to 72 hours after the drug administration, evaluated in two periods.

• Time to Cmax (Tmax)

  Time to obtain the maximum concentration

  Collections points from time 0 to 72 hours after the drug administration, evaluated in two periods.

Study Arms (2)

Sequence 1

ACTIVE COMPARATOR

01 tablet, single dose, of Reference Product in period 1 and 01 tablet, single dose, of Test Product in period 2.

Drug: Crestor®; Drug: rosuvastatin calcium tablets

Sequence 2

ACTIVE COMPARATOR

01 tablet of Test Product in period 1, and 01 tablet, single dose, of Reference Product in period 2.

Drug: Crestor®; Drug: rosuvastatin calcium tablets

Interventions

Crestor® DRUG

Reference formulation is rosuvastatin calcium tablets, 20mg, currently commercialized by AstraZeneca do Brasil Ltda., under the trademark Crestor®

Sequence 1; Sequence 2

rosuvastatin calcium tablets DRUG

Test formulation is rosuvastatin calcium tablets, 20 mg, produced by Laboratorios Phoenix S.A.I.C.F/Argentina for GlaxoSmithKline Brasil Ltda.

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Man or woman aged between 18 to 50 years. Women can not be pregnant nor breastfeeding, and man and woman commit to use an efficient contraceptive method along the entire study period;
• Volunteers of Asian descent, due to differences in the pharmacokinetics of rosuvastatin in this group of people;
• Volunteers cholecystectomy;
• Female subjects of childbearing potential must not become pregnant during the study period, thus, should be sexually inactive through abstinence or use of contraceptive methods the failure rate \<1%. Inactivity sexual abstinence should be consistent with the usual lifestyle of the subject. Periodic abstinence and withdrawal are not acceptable methods of contraception. Will be accepted as methods of contraception with failure rate less than 1%: oral contraceptives, either combined or progestogen alone, injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, Percutaneous contraceptive patches, intrauterine device (IUD) or intrauterine system (IUS ) that meets the failure rate \<1%, double barrier method, partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject;
• Body mass index ≥ 18.5 or ≤ 29.9 kg/m²;
• Volunteers with good health conditions and without significant diseases at medical criterion, as per the Clinical History; Blood pressure, pulse and temperature are taken, Physical examination, ECG and complementary Lab examinations;
• The volunteer is healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study;
• The volunteer must be able to understand nature and purpose of the study, including the risks and adverse effects and must show good intention to cooperate with the researcher and act according to the requirement of the entire trial, what is confirmed by the signature of an Informed Consent.

You may not qualify if:

• The volunteer has a known hypersensitivity to the drug being studied or to any chemically related compounds;
• History or existence of hepatic or GI diseases or any other condition that could interfere with the absorption, distribution, excretion or metabolism of the drug;
• Use of maintenance therapy with any drug but oral contraceptives;
• History of hepatic, renal, pulmonary, GI, neurological, hematological, psychiatric, cardiologic or allergic problem of any etiology that needs drug treatment or that the researcher considers it is clinically relevant;
• Current or chronic history of liver disease, or know hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstone);
• ECG findings, not recommended at the researcher's criterion to participate in the study;
• Results of complementary lab tests that are out of the values considered normal, according to this protocol guidelines, unless the researcher considers them non-clinically significant;
• Smoke abuse;
• Daily ingestion of more than five cups of coffee;
• History of alcohol or drug abuse;
• Use of regular medication along the two weeks that preceded the study commencement, or use of any other medication one week before the study commencement;
• Hospitalization for any reason up to 8 weeks before the first period of study;
• Treatment along three months before the treatment commencement of the study with any drug known because of its well-defined toxic potential to major organs;
• Participation in any pharmacokinetics study with collection of more than 300 mL of blood or ingestion of any experimental drug along six months before the treatment commencement of the study;
• Donation or loss of ≥ 450 mL of blood along the three months that preceded the study or donation of more than 1500 mL along the 12 months before the treatment commencement of the study;

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Bragança Paulista, São Paulo, 12916-900, Brazil

Location

Related Links

• Results for study 117120 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

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

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 22, 2012
• Study Start: February 25, 2013
• Primary Completion: March 13, 2013
• Study Completion: March 13, 2013
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

BR (1)