Healthy volunteers
Conditions
Interventions
Voriconazole 200 mg Film-
coated Tablets,Voriconazole 200 mg Film-
VFENDâ„¢ 200 mg,VONAZOLE (200 MG TABLET)
Sponsors
International Bio Service
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 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 (signed and dated) by the subject prior to participating in this study.
Exclusion criteria
Exclusion criteria: 1. History of allergic reaction or hypersensitivity to voriconazole or azole-related structure or any of the components of the product 2. History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological, endocrine (e.g. thyroid), pulmonary, cardiovascular (e.g. cardiomyopathy, arrhythmias, bradycardia), 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 illness 3. History or evidence of visual abnormality e.g. blurred vision, optic neuritis or papilledema 4. History or evidence of photosensitivity skin reaction, melanoma or skin rash 5. History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 6. History of problems with swallowing tablet 7. History of sensitivity to heparin or heparin-induced thrombocytopenia 8. Any condition possibly affecting drug absorption e.g. oral mucous membrane lesions, gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 9. History of preceding diarrhea or vomiting within 24 hours prior to admission in each period 10. History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 11. Have sitting systolic blood pressure of less than 90 mmHg or more than 139 mmHg and diastolic blood pressure of less than 60 mmHg or more than 89 mmHg on screening day or the day of admission. If abnormal blood pressure detects, the measurement should be repeated two more times after take a rest for at least 5 mins each. The last measurement value should be used to determine the subject’s eligibility. 12. 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 should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject’s eligibility. 13. Investigation with blood sample shows positive test for HBsAg. 14. Investigation with blood sample shows level of potassium less than 3.4 or more than 4.5 mmol/L at screening laboratory test. 15. Investigation with blood sample shows level of magnesium less than 1.6 or more than 2.4 mg/dL at screening laboratory test. 16. Investigation with blood sample shows level of total calcium less than 8.6 or more than 10.0 mg/dL at screening laboratory test. 17. Investigation with blood sample shows level of creatinine less than 0.51 or more than 0.95 mg/dL for female and less than 0.67 or more than 1.17 mg/dL for male at screening laboratory test. 18. Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test 19. 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. 20. 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 per
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration of Voriconazole 200 mg in human plasma 0,0.17,0.33,0.50,0.75,1,1.33,1.67,2,2.33,2.67,3,3.5,4,6,8,12,16,24,36 hr Pharmacokinetic evaluation (Cmax) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation 0-36 hr Adverse events e.g. dry mouth, headache, fatigue and somnolence | — |
Countries
Thailand
Contacts
Public ContactPorranee Puranajotu
International Bio Service
Outcome results
None listed