Bioequivalence study of Itraconazol 100mg capsule of Arya Pharm Co., IRA

Not Applicable

• Conditions: Fungal disease.

• Registration Number: IRCT20190706044111N1
• Lead Sponsor: Arya Pharm Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Aged between 20 - 50 years
body weight between 50 – 100 kg
Having good health on the basis of medical history and physical & clinical examination.
Understand the procedures and give written informed consent.

Exclusion Criteria

Subject showed clinically relevant deviations from normal in physical examination.
Subject had undergone surgery of the gastro-intestinal tract
Subject had donated a unit of blood or participated in another clinical trial, within the last 8 weeks before the first treatment.
Subject had a history of drug or alcohol abuse.
Subject who smokes more than 10 cigarettes per day.
Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment.
Subject had a history of allergic to itraconazol

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma concentration of Itraconazol and hydroxyitraconazol. Timepoint: Plasma related to 0, 1, 2, 3, 4, 4.5, 5, 6, 7, 8, 10, 24 and 48hr. after dosing. Method of measurement: HPLC.