A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of palonosetron after intravenous administration of palonosetron in healthy volunteers under fasting conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
16
Pharmacokinetic study under fasting conditions
Taichung Veterans General Hospital
Taichung, Taiwan
Peak concentration (Cmax)
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Time frame: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
Time to reach peak concentration (Tmax)
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Time frame: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC0-t)
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Time frame: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
Area under the concentration-time curve from time zero to infinity (AUC0-∞)
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Time frame: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
Elimination rate constant (入z)
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Time frame: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
Terminal elimination half-life (t1/2)
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The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Time frame: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
Ratio of AUC0-t to AUC0-∞
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Time frame: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose