To investigate bioequivalence information between test product,
Conditions
Interventions
Reference product manufactured by originator,Test product manufactured by sponsor (Lupin Limited)
Active Comparator Drug,Experimental Drug
EZETROL 10 mg,Ezetimibe Tablets 10 mg
Sponsors
Lupin Limited
Lupin Limited
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/m^2 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 breat feedings 5) Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progeterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 20 days prior to check-in in period 1 6)Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in period 1 until 7 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 the study
Exclusion criteria
Exclusion criteria: 1) History of allergic reaction or hypersensitivity to ezetimibe or to any excipients of tablet 2) History or evidence or clinically significant renal, hepatic including cholelithiasis, gastrointestinal, hematological (e.g.anemia), endocrine (e.g.thyroid, diabetes), pulmonary or respiratory (e.g.asthma), cardiovascular, psychiatric, neurologic (e.g.seizures), or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illess 3) History or evidence of muscular disease e.g. muscle pain, tenderness, weakness, myopathy or rhabdomyolysis 4) History of problems with swallowing tablet or capsule 5) History or evidence of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption 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 or vomiting within 24 hours prior to check-in in each period 9) History or evidence of drug addict or investigation with urine sample prior to check-in shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 10) 12-lead ECG demonstrating QTc>450 msec, a QRS interval >120 msec or with an abmormality 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 11) Investigation with blood sample shows positive test for HBsAg, Anti-HCV, Anti-HIV or reactive test for VDRL 12) Creatine kinase (CK) levels ≥ 1.5 times of upper normal limit of reference range (unless explained by exercise) at screening laboratory test 13) Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels 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 and continued for entire duration of the study 15) 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 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 17) History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 28 hours prior to check-in in period 1 and continued for entire duration of the study 18) 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 check-in in period 1 and continued for entire duration of the study 19) Use of prescription or nonprescription drugs (e.g. paracetamol, erythromycin, ketoconazole, cyclosporine, statins, fibrates etc.), herbal medications or supplements (e.g. St.John
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalent 24 sampling time points per period AUC0, Cmax determined from plasma concentration data of analytes | — |
Secondary
| Measure | Time frame |
|---|---|
| Bioequivalent 24 sampling time points per period Tmax, t1/2, MRT | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co., Ltd.
Outcome results
None listed