Itraconazole capsules in-vivo bioequivalence in healthy volunteers iranian

Pharmacokinetic assessments of Itraconazole capsules in comparison with brand drug SPRANOX

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N15

Enrollment

Registered

2020-11-03

Start date

2020-11-10

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In this study, the disease is not examined. Subject bioequivalence test and reference Itraconazole Capsules studied..

Interventions

Intervention 1: Intervention group: Single dose of Itraconazole Capsules 100 mg Kimidarou Company as a test product. Intervention 2: Control group: Single dose of Itraconazole Capsules with brand d

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: General health (liver, heart, kidney) Body Mass Index (BMI) between 18-28 Informed consent Age between 18-28 Both male and female

Exclusion criteria

Exclusion criteria: Smoking Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug

Design outcomes

Primary

Measure	Time frame
Determination of blood drug concentration. Timepoint: Sampling times in this study will be 0, 1, 2, 2:30, 3, 3:20, 3:40, 4, 4:20, 4: 40, 5, 6, 8, 10, 12, 24, 48, 72 hours. Method of measurement: Liquid Chromatography with tandem mass spectroscopy detector.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Shokri

Tabriz University of Medical Sciences

Shokri.j@gmail.com+98 41 3334 8489

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026