bioequivalence study

Not Applicable

• Conditions: The study will be performed on healthy volunteers..

• Registration Number: IRCT20230629058615N1
• Lead Sponsor: Behshad Daroo Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Volunteer’s health (based on the results of physical examinations and clinical tests)
Volunteer’s health (based on the results of physical examinations and clinical tests)
Body mass index of 18.5-30 kg/m2
No history of allergy to tetracycline antibiotics and excipients used in the products formulations
No administration of potent cytochrome p450 inhibitors 4 weeks before start of the study
No history of diseases affecting the pharmacokinetic processes of the drug
No history of smoking, alcohol and narcotics use
Not being pregnant or breastfeeding
Adherence to study criteria based on ethical commitment and informed consent
Absence of severe liver failure (Child Pugh B or C) or kidney failure (GFR<30 mL/min/1.73 m2)

Exclusion Criteria

Pregnancy
Tobacco or alcohol use, acute or chronic
Failure to obtain any of the mentioned items regarding health tests
Drug administration before and during the study
Lack of adherence to study criteria
Incidence of adverse reactions
liver failure (Child Pugh B or C) or kidney failure (GFR<30 mL/min/1.73 m2)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
C max- Tmax- AUC0-t. Timepoint: 0 - 0.5 - 1 -1.5 - 2 - 2.5 - 3 - 3.5 - 4 -4.5 - 6 - 8 - 10 to 12 - 24 -48 -72 Hours after drug administration. Method of measurement: Drug analysis will be performed using a high-performance liquid chromatography (HPLC) equipped with a UV detector.