Bioequivalence study Bioequivalence study Rosuvastatin
Conditions
Interventions
and not chew or crush the tablet. A single dose of Rosuvastatin 20 mg film-
coated tablets will be given with 240 mL of water. Investigational product will be administered directly from the unit dose-
the subject’s oral cavity will be checked by using flashlight and tongue depressor to confirm complete medication and fluid consumption by pharmacists. ,The marketed original products which were alr
the subject’s oral cavity will be checked by using flashlight and tongue depressor to confirm complete medication and fluid consumption by pharmacists.
Experimental Drug,Active Comparator Drug
coated tablets ,Crestor 20 mg tablets
Sponsors
Bio-innova and Synchron.Co.,Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Willingness to provide written informed consent prior to participate in the study. 2. Healthy male and female Thai subjects between 18 to 55 years of age (both inclusive). 3. The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2 (both inclusive). 4. Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 7 mL of blood for monitoring subjects’ safety after the completion of the study. 5. Negative urine pregnancy test for women, no intention to become pregnant over the course of the study and no breast-feeding. 6. Negative breath alcohol test on screening day 7. Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Any abnormalities or deviations outside the normal ranges for any of clinical testing (laboratory tests, EKG, vital signs) can be repeated at the discretion of the investigator(s) and judged to be not clinically significant for study participation. 8. For female volunteers, one of the following must apply: It is expected that women will take appropriate precautions against becoming pregnant and exposing a fetus to a potentially toxic agent as indicated below. 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: - intrauterine device (IUD) and intrauterine hormone-releasing system (IUS) used for at least 3 consecutive months prior to Period 1 dosing and willing to continue until 1 week from end of study - bilateral tubal occlusion - condom with intravaginally applied spermicides used for at least 14 days prior to Period 1 dosing and willing to continue until 1 week from end of study 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 considered to be of not childbearing potential must meet at least 1 of the following criteria unless we consider as childbearing: - who have had a documented hysterectomy, bilateral oophorectomy, bilateral salpingectomy or tubal ligation, - or who are clinically diagnosed infertile, - or who are in a menopausal state minimum of a year without menses (subjects statement is sufficient) and FSH level ≥35 IU/mL Note: Variations in the FSH levels will be acceptable at the medical discretion of the Principal Investigator after clinical co-relation. 9. For male volunteers, one of the following must apply in order to avoid impregnating a female partner, from the first study dose until 1 week post last dose: • Abstinence • Use of barrier method
Exclusion criteria
Exclusion criteria: 1. History or evidence of allergy or hypersensitivity to Rosuvastatin or HMG-CoA reductase inhibitors or any related drugs or any of the excipients of this product. 2. Subject with B.P. is Systolic B.P 100 beats per minute. 3. Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).* 4. Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).* 5. Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).* 6. Positive of hepatitis B surface antigen or hepatitis C antibody or HIV antibody. 7. Demonstrates a positive pregnancy test, pregnant, lactating, breastfeeding, or intends to become pregnant over the course of the study 8. Have more than one abnormal EKG, which is considered as clinically significant. * 9. History or evidence of heart, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension, or glaucoma. 10. History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy. 11. Any major illness in the past 3 months or any significant ongoing chronic medical illness. 12. History of psychiatric disorder. 13. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males within the past 1 year (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) and cannot stop at least 2 days before the study drug administration and until the completion of the study. 14. History of smoking within the past three months and not willing to refrain from smoking until the completion of the study. 15. High caffeine consumption (more than 5 cups of coffee or tea per day) and cannot stop at least 2 days before the study drug administration and until the completion of the study. 16. Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Methamphetamine, Cocaine and Opioids). 17. Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) preceding the first dose of study medication or over-the-counter (OTC) drugs or herbal medicines/food supplement within 14 days or hormonal methods of contraception within 28 days (Depo-Provera® must be discontinued at least 6 months) prior to receiving the first dose of study medication. Inducers / inhibitors of CYP enzymes (e.g. pimozide, terfenadine, astemizole, cisapride, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir, rifampin, carbamazepine, phenytoin) are not allowed from 28 days before dosing in Period 1 until the completion of the study. 18. History of difficulty in accessibility of veins in left and right arm. 19. Blood donation (one unit or 450 mL) within the past 3 months before the study. 20. Participation in any clinical study within the past 3 months before the study. 21. Subjects who are unwilling or unable to comply with the lifestyle guidelines described in this protocol. 22. Have had a tattoo or body piercing within 90 days prior to the first dose. 23. Presence of significant infection within 1 week prior to screening.* (* Depend on decision of principal investigator an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0→ t, AUC0→∞ 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.33, 3.67, 4, 4.33, 4.67, 5, 5.5, 6, 7, 9, 12, 24, 48, 72, 96 hr Pharmacokinetic parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; Adverse events 0, 2, 3 ,5, 6, 12, 24, 48, 72, 96 hr Safety monitoring, vital sign | — |
Countries
Thailand
Contacts
Public ContactSasitorn Kittivoravitkul
Bio-innova and Synchron.Co.,Ltd
Outcome results
None listed