Bioequivalence of generic rosuvastatin
Conditions
Interventions
label,
randomized,
day washout period between Period I and Period II,An open-
Experimental Drug,Experimental Drug
Rosuvastatin,Cresor
Sponsors
GETZ PHARMA INTERNATIONAL FZ LLC
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Healthy Thai male/female subjects between the ages of 18 to 55 years 2.Body mass index between 18.0-25.0 kg/m2 3.Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests 4.Non-pregnant woman (negative pregnancy test) and not currently breast feeding 5.Female subjects abstain from either hormonal method of contraception or hormone replacement therapy for at least 28 days prior to admission in period 1 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 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 rosuvasatin or related structure or any of the component of the formulation 2.History or evidence of clinically significant renal, heptatic, gastrointestinal hematological, endocrine, pulmonary or respiratory, cardiovascular, psychiatric disorder, neurologic or allergic disease or any significant ongoing chronic medical illness 3. History of muscular disease 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 problems with swallowing tablet 6.History of sensitivity to heparin or heparin-induced thrombocytopenia 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 hrs prior to admission in each period 9.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse 10.12-lead ECG demonstrating QTc>450 msec, a QRS interval > 120 msec or with an abnormality considered clinically significant at screenign 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.Renal creatinine clearance (CLcr) 1 unit (1 unit=350-450 mL of blood) within 90 days prior to admission in Period 1 or during enrollment 22. Subjects with poor venous access or intolerant to venepuncture 23. Unwilling or unable to comply with scheduled visits, treatment plan and other study procedures until end of study 24.Inability to communicate wel that may impair the ability to provide written informed consent or cooperate with clinical team 25.Subject who are employees of International Bio Service Co. Ltd., Getz Pharma International FZ LLC, Getz Pharma (PVT.) Ltd. or LF Asia (Thailand) Limited remark: Criteria for habitual use or regular beverage or regular smoke consumption will be followed SOPs of CRD.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t,AUC0-inf, Cmax 0,0.25,0.5,0.75,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,48 and 72 hrs post-dose Drug concentration in plasma,AUC0-t/AUC0-inf,Tmax, t1/2, AUC%extrapolate, MRT, 0,0.25,0.5,0.75,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,48 and 72 hrs post-dose Drug concentration in plasma | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event : Symptoms assessment 0.25,0.5,0.75,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,48 and 72 hrs post-dose Asking the question 'How do you feel?', Vital signs, Physical examination,Adverse event : Nephrotoxicity 0.25,0.5,0.75,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,48 and 72 hrs post-dose Collection of urine specimens ,Adverse event : Cardiotoxicity 0.25,0.5,0.75,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,48 and 72 hrs post-dose Electrocardiogram (ECG) | — |
Countries
Thailand
Contacts
Public ContactKongnapa Suvichakorn
LF Asia (Thailand) Limited
Outcome results
None listed