drugset / Trial / NCT05418348

Relative Bioavailability of Intravenous GTX-104 Compared to Oral Nimodipine Capsules in Healthy Subjects

NCT05418348

Phase 1 Completed 58 enrolled Grace Therapeutics Inc.
RandomizedCrossoverOpen-labelTreatment

Summary

This is a Phase 1, single center, randomized, two-period crossover study in healthy male and female subjects designed to evaluate the relative bioavailability (BA) and safety at steady state of two formulations of nimodipine: GTX 104 (nimodipine for intravenous \[IV\] infusion; test formulation) and nimodipine oral capsules, RS (reference formulation).

Timeline

Start
2021-08-26
Primary completion
2022-02-17
Completion
2022-02-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Nimodipine Small molecule 60 mg Intravenous