Randomized, four-way, four-period, fully-replicated, single oral dose, open-label, crossover, bioequivalence study to compare Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium) versus Cataflam® 50 coated tablet (50 mg Diclofenac Potassium), in healthy subjects under fasting condition
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
36
One Diclofenac tablet was administered orally.
One Diclofenac tablet was administered orally.
ACDIMA Biocenter
Amman, Jordan
Maximum observed plasma concentration (Cmax)
Statistical analysis of primary endpoints will include descriptive statistics, Analysis of Variance (ANOVA), and Confidence Interval (CI). The average bioequivalence of the products is concluded if the two-sided 90 % CI for the test to reference ratio of the population means is within 80.00 - 125.00 % for each of the Ln-transformed data for Cmax
Time frame: 10 hours
AUC0-t
Statistical analysis of primary endpoints will include descriptive statistics, Analysis of Variance (ANOVA), and Confidence Interval (CI). The average bioequivalence of the products is concluded if the two-sided 90 % CI for the test to reference ratio of the population means is within 80.00 - 125.00 % for each of the Ln-transformed data for AUC0-t
Time frame: 10 hours
AUC0-∞
Statistical analysis of primary endpoints will include descriptive statistics, Analysis of Variance (ANOVA), and Confidence Interval (CI). The average bioequivalence of the products is concluded if the two-sided 90 % CI for the test to reference ratio of the population means is within 80.00 - 125.00 % for each of the Ln-transformed data for AUC0-∞
Time frame: 10 hours
Tmax
The descriptive statistics including Maximum, Minimum and Median values will be measured for Tmax
Time frame: 10 hours
Thalf
Thalf was calculated from 0.693/ λz
Time frame: 10 hours
Kelimination
The terminal elimination rate constant (Kelimination or λz) was estimated for each subject and for each treatment via linear regression of the last points (at least three points will be used) at the terminal phase of the log-concentration versus time curve of each subject
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Time frame: 10 hours
Blood pressure (safety and tolerability)
Clinically significant abnormal deviations. Normal range of blood pressure \> 90/60 and \<140/90 mmHg.
Time frame: At pre-dosing, 2, 4, 6, 8, and 10 hours post dosing, ± 45 minutes of scheduled time
Pulse (safety and tolerability)
Clinically significant abnormal deviations. Normal range of Pulse 60-100 bpm.
Time frame: At pre-dosing, 2, 4, 6, 8, and 10 hours post dosing, ± 45 minutes of scheduled time
Temperature(safety and tolerability)
Clinically significant abnormal deviations. Normal range of temperature 36.5-37.5 ºC.
Time frame: At pre-dosing; 4, and 10 hours post dosing, ± 45 minutes of scheduled time