Bioequivalence study of Defrasirox tablets

Fasted-state bioequivalence study of film-coated Defrasirox 360 mg tablet manufactured by Aveina Co. in comparison to Jadenu (Novartis)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210519051345N2

Enrollment

Registered

2021-06-16

Start date

2021-07-27

Completion date

Unknown

Last updated

2021-06-21

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

Conditions

None listed

Interventions

Intervention 1: Intervention group 1 (test group): Defrasirox 360 mg tablet, produced by Avesina pharmaceutical co. is the test product. In each period, 12 of 24 subjects will be given single oral dos

Eligibility

Sex/Gender

Male

Age

25 Years to 55 Years

Inclusion criteria

Inclusion criteria: Healthy volunteer without any Heart, Liver and Kidney diseases

Exclusion criteria

Exclusion criteria: Having any diseases

Design outcomes

Primary

Measure	Time frame
Plasma drug concentration. Timepoint: 0.5-48 hours in predetermined time intervals. Method of measurement: HPLC.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParvin Zakeri-Milani

Tabriz University of Medical Sciences

pzakeri@tbzmed.ac.ir+98 41 3334 8801

Outcome results