Bioequivalence study in healthy Thai volunteers Ezetimibe Bioequivalence study, Healthy
Conditions
Interventions
Each tablet contains 10 mg of ezetimibe.,Each tablet contains 10 mg of ezetimibe.
Experimental Drug,Active Comparator Drug
Generic ezetimibe 10 mg tablets, EZECHOL,Ezetimibe 10 mg tablets, EZETROLTM
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 30.0 kg/m2. 3. Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. 4. Non-pregnant woman (negative pregnancy test) and not currently breast feeding. 5.Female subjects abstain from either hormonal method 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 check-in in Period 1. Injectable contraceptives e.g. Depo-Provera will be discontinued at least 6 months prior to check-in 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 check-in in Period 1 until 14 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 check-in 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 check-in in Period 1 until 14 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 ezetimibe or to any excipients of tablet. 2. History or evidence of clinically significant renal, hepatic including cholelithiasis, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper/hypothyroidism, diabetes mellitus), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper/hypotension), psychiatric, neurologic (e.g. seizures), 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 muscular disease e.g. muscle pain, tenderness, weakness, myopathy or rhabdomyolysis. 4. History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. 5. History of problems with swallowing tablet or capsule. 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 diarrhea or vomiting within 24 hours prior to check-in 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 is greater than450 msec, a QRS interval is greater than120 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 subjects eligibility. 11.Investigation with blood sample shows positive test for HBsAg. 12.Abnormal liver function, is greater than or equal to1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test. 13.Creatine phosphokinase (CPK) levels is greater than or equal to 1.5 times of upper normal limit of reference range (unless explained by exercise) at screening laboratory test. 14.History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study. 15.History or evidence of alcoholism or harmful use of alcohol within 2 years prior to screening 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.). 16.History or evidence of alcohol consumption or alcohol-containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 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 subjects eligibility which must be 0 mg%BAC. 17.History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration (Cmax), Truncated AUC0-72 will be determined from the plasma concentration data of analytes. 0-72 hours post dose Mass spectrometry (LC-MS/MS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of the maximum plasma concentration (Tmax) , The elimination half-life (t1/2) and lambdaz will be determined from the plasma concentration data of analytes. 0-72 hours post dose Mass spectrometry (LC-MS/MS) | — |
Countries
Thailand
Contacts
Public ContactThanaporn Wongyai
International Bio Service Co., Ltd.
Outcome results
None listed