At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-Label, Placebo-Controlled, Two-Period Crossover Study of the Effect on CTx-1 Concentrations of a Single 200 μg Recombinant Salmon Calcitonin (rsCT) Dose Given at Night to Normal, Healthy, Postmenopausal Women
In Brief
A Phase 2 clinical trial evaluating Oral rsCT tablet, Oral Placebo Tablet, and 1 other intervention for Phase 1 Pharmacodynamic Study. Completed, enrolled 12 participants across 1 site.
Detailed Summary
This study is being conducted to assess the plasma CTx-1 concentrations when dosing is at night and to compare these results with those obtained with a placebo control and with commercially available nasal calcitonin.
Study Details
Timeline
Interventions
On Study Day 1, subjects will be given their assigned treatment, based on one of two randomly ordered treatment sequences, at 10 PM (22:00). On Visit 3, subjects will return for administration of the second treatment with a minimum of 7 days washout interval between study drug administrations. On Visit 4, subjects will return for administration of third treatment of rsCT, either oral rsCT tablets or Fortical (rsCT) nasal spray. Interventions are described in Intervention Name, Other Names and in Intervention Description.
Part 1, Double blind oral placebo tablet given once 4 hours after evening meal.
Part 2, Open-label, oral rsCT tablet given once 2 hours after the evening meal.
Intervention: Open label, Fortical nasal spray given once 2 hours after the evening meal.