The purpose of this study was to demonstrate the bioequivalence of Deflox® 50 milligrams (mg) tablets compared with Cataflam® DD tablets 50 mg administered as single dose in fasting conditions to healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Participants received a single oral dose of 50 mg Deflox® tablet in either treatment period 1 or 2 under fasting conditions.
Participants received a single oral dose of 50 mg Cataflam DD® tablet in either treatment period 1 or 2 under fasting conditions.
Clinica de Enfermedades Crónicas y de Procedimientos Especiales S.C.
Morelia, Mexico
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Diclofenac
Time frame: Pre-dose up to 24 hours Post-dose
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Diclofenac
Time frame: Pre-dose up to 24 hours Post-dose
Maximum Observed Plasma Concentration (Cmax) of Diclofenac
Time frame: Pre-dose up to 24 hours Post-dose
Time to Reach Maximum Plasma Concentration (Tmax) of Diclofenac
Time frame: Pre-dose up to 24 hours Post-dose
Terminal Elimination Half-Life (t1/2) of Diclofenac
Time frame: Pre-dose up to 24 hours Post-dose
Apparent Volume of Distribution During Terminal Phase (Vz/f) of Diclofenac
Time frame: Pre-dose up to 24 hours Post-dose
Apparent Total Body Clearance of Drug From Plasma (CL/f) of Diclofenac
Time frame: Pre-dose up to 24 hours Post-dose
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: Baseline up to 15 days (end of study)
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
Time frame: Baseline up to 15 days (end of study)
Number of Participants With Clinically Significant Abnormalities in Vital Signs
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Time frame: Baseline up to 15 days (end of study)
Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG)
Time frame: Baseline up to 15 days (end of study)