To demonstrate that a single dose of Makena® delivered SQ via auto-injector has comparable bioavailability to a single IM injection of Makena®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
Unnamed facility
Anaheim, California, United States
Unnamed facility
DeLand, Florida, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Comparison of Areas Under the Curve (AUC) to the Last Time With a Concentration ≥ LLOQ [AUC0-t] and to Infinity [AUCinf]
Comparison of areas under the curve (AUC) to the last time with a concentration ≥ LLOQ \[AUC0-t\] and to infinity \[AUCinf\] for the Primary PK Population
Time frame: 9 weeks
Comparison of the Maximum Plasma Concentration (Cmax)
Comparison of the maximum plasma concentration (Cmax) for the Primary PK Population
Time frame: 9 weeks
Comparison of Tmax
Comparison of PK parameter Tmax for the Primary PK population
Time frame: 9 weeks
Comparison of AUC (0-168)
Comparison of PK Parameter AUC (0-168) for the Primary PK Population
Time frame: 9 weeks
Comparison of t1/2
Comparison of PK parameter t1/2 for the Primary PK Population
Time frame: 9 weeks
Comparison of Elimination Rate Constant
Comparison of the elimination rate constant for the Primary PK Population
Time frame: 9 weeks
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San Antonio, Texas, United States