Comparative in vivo evaluation of 2 Ciprofloxacine 500 mg Tablet formulations.

Not Applicable

• Conditions: A49.8; Bacterial infections.; Other bacterial infections of unspecified site

• Registration Number: IRCT20180620040164N62
• Lead Sponsor: Cosar Pharmaceutical Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Healthy subjects (male) between 18 – 50 years of age and Body Mass Index (BMI) within 15% of normal range between 18.5 - 30 kg/m2.
Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
ubjects that have normal vital signs.
Subjects who agree with patient consent form.

Exclusion Criteria

Previous history of allergy to a fluoroquinolone or severe allergic reaction to any medication.
History of CNS disorders (e.g. convulsive seizures).
History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neuromuscular, psychiatric, auto-immune or neurological disorders.
Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
Subjects who has used any drug including prescription or Over-The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during study period.
Heavy drinker of caffeine, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity.
A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study.

Study & Design

• Study Type: interventional
• Study Design: Not specified