Bioequivalence Study,
Conditions
Interventions
Active Comparator Drug,Active Comparator Drug
Atorvastatin plasma concentration (test product),Atorvastatin plasma concentration (reference product)
Generic Atorvastatin 40 mg FCT,LIPITOR,
Reg.
No. 1C10/59 (N). Manufactured by Pfizer Pharmaceuticals LLC,
Bangkok,
Thailand. Each tablet contains atorvastatin calcium
(crystalline form) equivalent to 40 mg atorvastatin.
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 18.5 to 25.0 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 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. 6.Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to admission in Period 1. Injectable contraceptives e.g. Depo-Provera® will 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 4. 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 7.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 4 8.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 atorvastatin 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. hypothyroidism), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. transient ischemic attack, stroke), 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 or evidence of muscle disease e.g. myalgia, myopathy, muscle weakness, muscle tenderness, rhabdomyolysis 4.History of problems with swallowing tablet or capsule 5.History of sensitivity to heparin or heparin-induced thrombocytopenia 6.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 7.History of preceding diarrhea within 24 hours prior to admission in each period 8.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 9.12-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. 10.Investigation with blood sample shows positive test for HBsAg 11.Active liver disease or abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test 12.Creatine kinase levels >3 times of upper normal limit of reference range at screening laboratory test 13.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 45 mL of 40% distilled spirits, such as rum, whisky, brandy etc.) 14.History or evidence of alcohol consumption or alcohol-containing products and cannot abstain for at least 48 hours prior to admission and continued for entire duration of the study or alcohol breath test shows positive result In case of alcohol breath test result represents the alcohol concentration range of 1 - 10 mg% BAC and the physician carefully considers that the value came from other reasons, not from the alcohol drinking behavior of subjects, the test will be repeated two times separately, not more than 10 minutes. The result of the last time should be used for subject‟s eligibility which must be 0 mg%BAC. 15.History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 48 hours prior to admission and continued for entire duration of the study 16.Consume or drink juice of grapefruit or orange or pomelo or its supplement/containing products and cannot abstain for at least 7 days prior to admission and continued for entire duration of the study 17.Use of prescription or nonprescription drugs (e.g. azithromycin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration of atorvastatin and its metabolites, ortho- and parahydroxylated atorvastatin 0-72 hrs Cmax, AUC0-tlast and AUC0-∞ | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood concentration of atorvastatin and its metabolites, ortho- and parahydroxylated atorvastatin 0-72 hrs AUC0-tlast/AUC0-∞, AUC%extrapolate, λz and MRT | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co.,Ltd
Outcome results
None listed