Bioequivalence Study,
Conditions
Interventions
Generic rosuvastatin 20 mg film-
coated tablet,
Each tablet contains 20 mg of rosuvastatin as rosuvastatin calcium.,Rosuvastatin 20 mg film-
CRESTOR 20
mg,
manufactured by IPR
Pharmaceuticals Inc.,
Puerto Rico and will be
imported by AstraZeneca (Thailand) Ltd.,
Bangkok,
Thailand. Each tablet contains 20 mg of rosuvastatin as
rosuvastatin calcium.
Active Comparator Drug,Active Comparator Drug
Rosuvastatin plasma concentrations (test product),Rosuvastatin plasma concentrations (reference product)
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 30.0 kg/m2. 3 Non-smoker and/or non-consumer of nicotine containing products. Non-smoker means any subject who has never smoked or stopped for at least 90 days whereas non-consumer of nicotine containing products means any subject who stopped nicotine containing product consumption for at least 90 days. 4 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. 5 Non-pregnant woman (negative pregnancy test) and not currently breast feeding. à¸à¸²à¸ªà¸²à¸ªà¸¡à¸±à¸„รเพศหà¸à¸´à¸‡à¹„ม่มีà¸à¸²à¸£à¸•à¸±à¹‰à¸‡à¸„รรภ์ (ผลà¸à¸²à¸£à¸•à¸£à¸§à¸ˆà¸à¸²à¸£à¸•à¸±à¹‰à¸‡à¸„รรภ์ให้ผลลบ) à¹à¸¥à¸°à¹„ม่à¸à¸¢à¸¹à¹ˆà¹ƒà¸™à¸ าวะให้นม บุตร 6 For female subjects, one of the following must apply: Females of childbearing potential will have to take appropriate measures to prevent pregnancy during the study, such as total abstinence or the use of highly effective contraceptive regimens. Highly effective methods of birth control are defined as those, alone or in combination that result in a low failure rate (i.e. less than 1% per year). Below is a list of acceptable contraceptive regimens throughout the study until duration equal to 1 washout period post last dose: ï€ combined (estrogen and progesterone containing) hormonal contraceptives associated with inhibition of ovulation (oral, intravaginal or transdermal) used for at least 3 consecutive months prior to Period 1 dosing ï€ progestogen-only hormonal contraceptives associated with inhibition of ovulation (oral, injectable or implantable) used for at least 3 consecutive months prior to Period 1 dosing ï€ intrauterine device (IUD) and intrauterine hormone-releasing system (IUS) used for at least 3 consecutive months prior to Period 1 dosing ï€ bilateral tubal occlusion ï€ condom with intravaginally applied spermicides used for at least 14 days prior to Period 1 dosing Females who do not use an acceptable contraceptive regimen or confirm total abstinence will be allowed to participate in this study only if they are not considered to be of childbearing potential: females ï‚· who have had a documented hysterectomy, bilateral oophorectomy, bilateral salpingectomy or tubal ligation, ï‚· or who are clinically diagnosed infertile, ï‚· or who are in a menopausal state (minimum of a year without menses (FSH level >35 IU/mL + no menses since at least 1 year; subjects statement is sufficient). Note: Variations in the FSH levels will be acceptable at the medical discretion of the Principal Investigator or delegated Clinical Investigator after clinical corelation. 7 For male subjects, one of the following must apply in order to avoid impregnating a female partner, from the first study dose until duration equal to 1 washout period post last dose: ï‚· Abstinence ï‚· Use of barrier method with spermicide 8 Subjects have understood and voluntarily given written informed consents (signed and dated) by the subject prior to
Exclusion criteria
Exclusion criteria: 1 History of allergic reaction or hypersensitivity to rosuvastatin or to any of the excipients of the product 2 History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hypo/hyperthyroidism), pulmonary or respiratory (e.g. allergic rhinitis, asthma), cardiovascular, psychiatric, neurologic (e.g. convulsion), 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 diseases i.e. myopathy, myalgia, rhabdomyolysis, muscle tenderness or weakness or personal or family 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 glucosegalactose malabsorption 5 History of problems with swallowing tablet or capsule 6 History of sensitivity to heparin or heparin-induced thrombocytopenia 7 Reports difficulty fasting or consuming standardized meals 8 Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 9 History of preceding diarrhea within 24 hours prior to check-in in each period 10 Presence of significant infection within 1 week prior to screening or check-in 11 History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana, methamphetamine, benzodiazepine or cocaine) 12 Have had a tattoo or body piercing within 90 days prior to check-in in Period 1 or during enrollment 13 Reports a clinically significant illness during the 30 days prior to check-in in Period 1 or during enrollment{as determined by the investigator(s)} 14 Pulse rate below 60 beats/minute or above 100 beats/minute 15 Systolic blood pressure less than 90 mmHg or more than 139 mmHg. Diastolic blood pressure less than 60 mmHg or more than 89 mmHg. Minor deviations (2-4 mmHg) at check-in may be acceptable at the discretion of the physician/ investigator. 16 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 will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject’s eligibility. 17 Investigation with blood sample shows positive test for HBsAg, Anti-HCV or AntiHIV 18 Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test 19 Creatine kinase levels ≥ 1.5 times of upper normal limit of reference range (unless explained by exercise) at screening laboratory test 20 Have renal creatinine clearance (Clcr) <30 mL/min based on serum creatinine results, using glomerular filtration rate (GFR; Cockcroft-Gault formula), at the screening laboratory test 21 History or evidence of alcoholism or harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rosuvastatin plasma concentrations 0-96 hr. Cmax, AUC0-tlast and AUC0-∞ | — |
Secondary
| Measure | Time frame |
|---|---|
| Rosuvastatin plasma concentrations 0-96 hrs. Tmax, t1/2, AUC0-tlast/AUC0-∞, AUC%extrapolate, λz and MRT | — |
Countries
Thailand
Contacts
Public ContactPorranee Puranajoti
International Bio Service Co., Ltd
Outcome results
None listed