Bioequivalence study of phenazopyridine hydrochloride 100 mg tablet

Bioequivalence study of phenazopyridine hydrochloride 100 mg tablets of Mehr Darou pharmaceutical company compared to the phenazopyridine hydrochloride 100 mg sample of Pfizer in Germany on healthy volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230222057495N11

Enrollment

Registered

2023-12-16

Start date

2023-12-16

Completion date

Unknown

Last updated

2024-01-22

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: includes the oral consumption of 100 mg phenazopyridine hydrochloride tablets of Mehr Darou Pharmaceutical Company of Iran on 24 healthy fasting volunteers. 5 ml

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Healthy volunteer between 18 and 55 years old. Body mass index less than 30 kg per square meter. All candidates must be non-smokers.

Exclusion criteria

Exclusion criteria: Blood pressure less than 90 on 60 mm Hg or more than 140 on 90 mm Hg Consumption of any drug, alcohol or tobacco within 2 weeks before receiving the drug

Design outcomes

Primary

Measure	Time frame
The maximum plasma concentration of phenazopyridine hydrochloride. Timepoint: Before taking the drug and: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours after taking the drug. Method of measurement: Liquid chromatography-mass spectrometry.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMonireh Jalalipour

Nik Azma Pars Alborz laboratory

info@naplab.ir+98 26 3731 8748

Outcome results