Area Under the Plasma Concentration Verse Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) of Teduglutide by Injection Site
Time frame · Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
Registry description
AUC0-last of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.
Maximum Observed Plasma Concentration (Cmax) of Teduglutide by Injection Site
Time frame · Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
Registry description
Cmax of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Teduglutide by Injection Site
Time frame · Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
Registry description
AUC0-infinity of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.
Time of First Occurrence of Maximum Observed Plasma Concentration (Cmax) [Tmax] of Teduglutide
Time frame · Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
Terminal Disposition Phase Rate Constant (Lambda z) of Teduglutide
Time frame · Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
Terminal Disposition Phase Half-Life (t1/2z) of Teduglutide
Time frame · Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
Apparent Total Body Clearance (CL/F) of Teduglutide
Time frame · Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
Registry description
CL/F for extravascular administration divided by the fraction of dose absorbed of teduglutide was assessed and reported.
Apparent Volume of Distribution (Vz/F) of Teduglutide
Time frame · Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
Registry description
Vz/F associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed of teduglutide was assessed and reported.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame · From the start of study drug administration up to follow-up (up to 42 days)
Registry description
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an AE that started or worsened at the time of or after study drug administration. Number of participants with TEAEs included injection site reactions and injection site injury assessments.
Number of Participants With Clinically Significant Change in Vital Signs
Time frame · From the start of study drug administration up to follow-up (up to 42 days)
Registry description
Vital signs included body temperature, respiratory rate, blood pressure, and heart rate.
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
Time frame · From the start of study drug administration up to follow-up (up to 42 days)
Registry description
Clinical laboratory assessments included hematology, serum chemistry, coagulation, and urinalysis. Changes in laboratory values may be considered as AE if they were judged to be clinically significant.
Number of Participants With Clinically Significant Changes in Physical Examinations
Time frame · From the start of study drug administration up to follow-up (up to 42 days)
Registry description
Physical examination included examination of respiratory, cardiovascular, and gastrointestinal system.
Number of Participants With Device Malfunction
Time frame · Day 1
Registry description
Number of participants with device malfunction was assessed and reported. The site staff reported any malfunctions whilst using the device.