Bioequivalence of Gemifloxacin

Single-dose bioequivalence studies of Gemifloxacin tablets (320 mg) in healthy volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210201050197N3

Enrollment

Registered

2021-03-08

Start date

2021-02-04

Completion date

Unknown

Last updated

2021-04-26

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

Conditions

Healthy subjects.

Interventions

Intervention 1: Intervention group: Receiving Iranian medicine (generic product): In this group, each volunteer receives a 320 mg gemifloxacin tablets made by Aria Company during a treatment period. A

Eligibility

Sex/Gender

Male

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Healthy volunteer Age: 18-50 year

Exclusion criteria

Exclusion criteria: History of liver, kidney and cardiovascular diseases that can affect drug clearance from body History of taking any medication in the last two weeks Creatinine above 2

Design outcomes

Primary

Measure	Time frame
Plasma drug concentration. Timepoint: 20, 40 Mins, 1,1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24 Hours. Method of measurement: High performance liquid chromatography (HPLC) method.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzadeh Haeri

Shahid Beheshti University of Medical Sciences

a_haeri@sbmu.ac.ir+98 21 8820 0212

Outcome results

None listed

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