An open label, prospective, double arm clinical study to compare the effectiveness and safety of super bioavailable Itraconazole capsules 50 mg BD vs 65 mg BD in the management of Glabrous tinea

Dr Deval Mistry0 个研究点目标入组 100 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•Patients eligible for enrolment in the study must meet all of the following criteria:
•1. Both male and female patients aged Ã¢â?°Â¥ 18 years and Ã¢â?°Â¤ 60 years.
•2. Patients with diagnosis of Glabrous tinea on KOH mount requiring systemic antifungal therapy.
•3. Females of child bearing potential, who is prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom with spermicide, IUD, oral, injected, transdermal or implanted hormonal contraceptives).
•4. Patients who are ready to give written informed consent, which includes a commitment to comply with all requirements, specified in the study protocol, among others a negative urine pregnancy test in the case of women of childbearing age.
•5. Patients who the study staff deems reliable and mentally competent to carry out the study.

•Patients meeting any of the following criteria must not be enrolled in the study:
•1. Pregnant or nursing females.
•2. Patients with known hypersensitivity to the study drugs.
•3. Patients with liver dysfunction.
•4. Patients with a history of seizures
•5. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subjectÃ¢â?¬•s safety or interfere with the study assessments.
•6. Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the subjectÃ¢â?¬•s ability to safely complete the study.
•7. History of drug or alcohol dependency or abuse within approximately the last 2 years.
•8. Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or were scheduled to participate in another clinical study that involved an investigational product or investigational drug during the course of this study.
•9. Patients with malignancy.
•10. Any patient whom the investigator judged to be inappropriate for this study.

发起方

Dr Deval Mistry