Comparative Randomized, Single Dose, Two-Way Crossover, Open-Label Study to Determine the Bioequivalence of Ezetimibe 10 mg Tablets Formulations, EZETROL and Ezetimibe GPO, after Oral Administration to Healthy Thai Volunteers under Fasting Conditions
- Conditions
- Healthy volunteers
- Registration Number
- TCTR20171206001
- Lead Sponsor
- The Government Pharmaceutical Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 70
1. Healthy Thai male/female subjects between the ages of 18 to 55 years.
2. Body mass index between 18.0 to 25.0 kg/m2.
3. 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.
4. Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
5. 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. 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.
6. 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.
7. Have voluntarily given written informed consent by the subject prior to participating in this study (signed and dated in Informed Consent Form and HIV-Specific Model Consent forms).
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, endocrine e.g. thyroid, diabetes etc. pulmonary or respiratory e.g. asthma, cardiovascular, psychiatric, neurologic e.g. convulsion, or 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 evidence of muscular disease e.g. muscle pain, tenderness, weakness, myopathy or rhabdomyolysis.
4. History of problems with swallowing tablet.
5. History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
6. History of sensitivity to heparin or heparin-induced thrombocytopenia.
7. Any conditions 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 admission in each period.
9. History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (benzodiazepine, cocaine, morphine, marijuana or methamphetamine).
10. 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.
11. Investigation with blood sample shows positive test for HBsAg, Anti-HCV or anti-HIV.
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 7 days prior to admission and continued until last sample collection in each study period.
15. History or evidence of alcoholism, regular alcohol consumption or alcohol-containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period.
16. History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period.
17. Consume or dring juice of grapefruit, orange, citrus or pomelo or its supplement/containing products (excluding consumption of citrus as ingredient in food such as som tom, tom yum etc.) and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period.
18. Use of prescription or nonprescription drugs e.g. paracetamol, erythromycin, ketoconazole, cyclosporine, statins, fibrates etc., herbal medications or supplements e.g. St. John's wort, iron, vitabmins or dietary supplements within 14 days prior to admission in Period 1 or during enrollment.
19. Par
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method