Aim of this study is to demonstrate the bioequivalence of single subcutaneous doses of XM17 and Gonal-f® in a confirmatory design. Furthermore, safety and tolerability will be assessed in human healthy female subjects. Only female subjects will be included in the study to reach the objectives of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Comparison of single dose pharmacokinetics (Cmax)
XM17 and Gonal-f® tested statistically for bioequivalence.
Time frame: Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Comparison of single dose pharmacokinetics (AUC0-t)
XM17 and Gonal-f® tested statistically for bioequivalence.
Time frame: Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Pharmacokinetics AUC0-∞
Area under the XM17 / Gonal-f® concentration time curve from time 0 extrapolated to infinity
Time frame: Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Pharmacokinetics AUC0-168h
Area under the XM17 / Gonal-f® concentration time curve from time 0 to 168 h
Time frame: Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Pharmacokinetics Cmax,obs
Maximum XM17 / Gonal-f® concentration determined during the interval of sample taking
Time frame: Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Pharmacokinetics Tmax
Time to maximum XM17 / Gonal-f® concentration
Time frame: Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Pharmacokinetics λZ
Apparent terminal elimination rate constant.
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Time frame: Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Pharmacokinetics t1/2
Apparent terminal elimination half life.
Time frame: Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Pharmacokinetics CL/F
Serum clearance after dosing
Time frame: Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Pharmacokinetics Vz/F
Volume of Distribution during the terminal phase after extravascular administration
Time frame: Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Percentage of participants with adverse events
Time frame: Signing of informed consent to final data collection (27 days)