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PK/Safety of Rayaldee in Healthy Japanese and Non-Japanese Subjects
NCT03660800Phase 1Completed
- Sponsor
- OPKO Health
- Start
- Aug 2018
- Primary completion
- Oct 2018
- Modality
- Orthosteric Ligands
- Countries
- 1
01
Overview
Phase 1, randomised, open-label trial of calcifediol in Vitamin D deficiency (VDD) and secondary hyperparathyroidism (SHPT) (4 arms), sponsored by OPKO Health. Primary endpoints: Number of participants with treatment-related Adverse Events at 8 weeks, Change in baseline of peak plasma concentration at 8 weeks and 1 more. Started Aug 2018; status: completed.
02
Drugs
calcifediol
03
Conditions
Vitamin D deficiency (VDD)secondary hyperparathyroidism (SHPT)
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