An open label, balanced, randomized, single dose, two treatment, two sequence, two period, two way crossover oral bioequivalence study in healthy, adult, human subjects under fasting condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
1 tablet of Empagliflozin + Linagliptin 25 mg/5 mg film-coated tablets
1 tablet of Glyxambi 25 mg/ 5 mg film-coated tablets
Veeda Clinical Research Ltd.
Ahmedabad, Gujarat, India
For Empagliflozin; Peak Plasma Concentration (Cmax)
The 90% confidence intervals for the difference between least square means of test (T) and reference (R) formulations will be calculated using mean square error, obtained in ANOVA, for ln-transformed pharmacokinetic parameters Cmax and AUC0-t for Empagliflozin \& Cmax and AUC0-72 for Linagliptin.
Time frame: 72 hours
For Empagliflozin; The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration, calculated using linear trapezoidal method (AUC0-t)
The 90% confidence intervals for the difference between least square means of test (T) and reference (R) formulations will be calculated using mean square error, obtained in ANOVA, for ln-transformed pharmacokinetic parameters Cmax and AUC0-t for Empagliflozin \& Cmax and AUC0-72 for Linagliptin
Time frame: 72 hours
For Linagliptin; Peak Plasma Concentration (Cmax)
The 90% confidence intervals for the difference between least square means of test (T) and reference (R) formulations will be calculated using mean square error, obtained in ANOVA, for ln-transformed pharmacokinetic parameters Cmax and AUC0-t for Empagliflozin \& Cmax and AUC0-72 for Linagliptin
Time frame: 72 hours
For Linagliptin; Area Under the Curve from time zero to time of last measurable concentration (AUC0-72)
The 90% confidence intervals for the difference between least square means of test (T) and reference (R) formulations will be calculated using mean square error, obtained in ANOVA, for ln-transformed pharmacokinetic parameters Cmax and AUC0-t for Empagliflozin \& Cmax and AUC0-72 for Linagliptin
Time frame: 72 hours
For Empagliflozin; Area Under the Curve from time zero to time infinite (AUC0-∞)
Descriptive Statistic
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Time frame: 72 hours
For Empagliflozin; Time to reach peak plasma concentration (Tmax)
Descriptive Statistic
Time frame: 72 hours
For Linagliptin; Time to reach peak plasma concentration (Tmax)
Descriptive Statistic
Time frame: 72 hours