Healthy volunteers Rosuvastatin, Bioequivalence Study, Healthy Thai Volunteer
Conditions
Interventions
coated tablet (Test product),Rosuvastatin 20 mg film-
Experimental Drug,Active Comparator Drug
Rosuvastatin 20 mg,CRESTOR 20 mg
Sponsors
International Bio Service Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Healthy Thai male or female subjects between the ages of 18 to 55 years 2.Body mass index between 18.0 to 25.0 kg/m2 3.Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study. 4.Non-pregnant woman (negative pregnancy test) and not currently breast feeding 5.Female subjects abstain from either hormonal methods of contraception or hormone replacement therapy for at least 28 days prior to admission in Period 1. Injectable contraceptives e.g. Depo-Provera must be discontinued at least 6 months prior to admission in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to admission in Period 1 until 7 days after the end of study in Period 2. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to admission in Period 1: Postmenopausal for at least 1 year or Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months 6.Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after admission in Period 1 until 7 days after the end of study in Period 2 7.Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study
Exclusion criteria
Exclusion criteria: 1.History of allergic reaction or hypersensitivity to rosuvastatin or related structure or any of the components of the product 2.History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. thyroid), pulmonary or respiratory (e.g. asthma), cardiovascular, psychiatric (e.g. depress), neurologic (e.g. seizure), or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness 3.History of muscular disease i.e. myopathy, myalgia, rhabdomyolysis, muscle tenderness or weakness or hereditary muscular disorders or history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate 4.History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 5.History of sensitivity to heparin or heparin-induced thrombocytopenia 6.History of problems with swallowing tablets or capsules 7.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 8.History of preceding diarrhea within 24 hours prior admission in each period 9.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 10.12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subjects eligibility. 11.Investigation with blood sample shows positive test for HBsAg 12.Abnormal liver function, >= 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test 13.Creatine kinase levels > 1.5 times of upper normal limit of reference range (unless explained by exercise) at screening laboratory test 14.Have renal creatinine clearance (CLCr) < 30 mL/min based on serum creatinine results at the screening laboratory test 15.History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period 17.History or evidence of alcoholism, regular alcohol consumption or alcohol-containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period 18.History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period 19.Consume or drink juice of grapefruit, orange, pomelo or pomegranate or its supplement/ containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period 20.Use of prescription or nonprescription drugs (e.g. paracetamol, erythromycin, ketoconazole, atorvastatin), herbal medications or supplements (e.g. St. John's wort), vitamins or mineral (e.g. iron) or dietary supplements within 14 days prior to admission in Period 1 or during enrollment 21.Participated in other clinical trial within 90 days or ongoing long-term clinical trial prior to a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rosuvastatin plasma concentrations 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72 h Cmax, AUC0-tlast and AUC0-inf | — |
Secondary
| Measure | Time frame |
|---|---|
| Rosuvastatin plasma concentrations 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72 h Tmax, t1/2, λz, AUC0-tlast/AUC0-inf, AUC%extrapolate and MRT | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co., Ltd.
Outcome results
None listed