A Phase 1 interventional study of Teriparatide and Oral PTH (1-34) in Drug Safety and Bioavailability, sponsored by Entera Bio Ltd.. Completed. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-10.
Sponsored by Entera Bio Ltd. · Phase 1, Interventional, and Treatment
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.
Entera Bio Ltd. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subcutaneous injection of Teriparatide
Drug: Teriparatide
Oral administration of pill with API with different optimizations
Drug: Oral PTH (1-34)
subcutaneous standard injection
Different optimization of API
Also known as: Teriparatide
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
No study locations are listed for this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Entera Bio Ltd.