Bioequivalence study of PuricCidal® (ciprofloxacin) 750mg tablet of Kharazmi Pharm. Co., IRAN

Bioequivalence study of PuricCidal® (ciprofloxacin) 750mg tablet of Kharazmi Pharm. Co., IRAN in comparison of Sandoz Ciprofloxacin 750mg tablet in 24 healthy adult subjects under fasting condition

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190706044111N35

Enrollment

Registered

2024-05-14

Start date

2023-06-22

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Bacterial infections. Long term (current) use of antibiotics

Interventions

Intervention 1: Intervention group: One oral tablet of PuricCidal® (ciprofloxacin) 750mg of Kharazmi Pharm. Co., single dose, in fasting condition. Intervention 2: Control group: One tablet of Sandoz

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: - Aged between 18 - 50 years - Body weight between 50 – 100 kg - Having good health on the basis of medical history and physical & clinical examiation - Understand the procedures and give written informed consent

Exclusion criteria

Exclusion criteria: 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 two months 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.

Design outcomes

Primary

Measure	Time frame
Plasma concentration of Ciprofloxacin. Timepoint: 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 & 24.0 hr. after dosing. Method of measurement: Using High Performance Liquid Chromatography wit UV detector (HPLC/UV).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLadan Tayebi

Pars Biopharmacy Research Co.

l.tayebi@parsbiopharmacy.com+98 21 8895 6061

Outcome results

None listed

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