This study will have one stage consisting of multiple treatment visits. The study is designed to assess the safety and bioavailability of Entera's oral PTH(1 - 34) in adult male healthy volunteers in various formulation. The study is also designed to assess the reproducibility of pharmacokinetic profiles with various formulations.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
subcutaneous standard injection
Different optimization of API
Peak Plasma Concentration
Blood samples for determination of PTH plasma concentrations will be taken at the time points to study the pharmocokinetc profile
Time frame: 60-522 days
Adverse Events
throughout the study beginning from the time the subject signs the consent form until the end of study, subjects will complete the following evaluations: Vital signs (blood pressure, heart rate, oral temperature) Clinical laboratory evaluations, hematology, chemistry Physical Exam ECG
Time frame: 60-522 days
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