Status:
COMPLETED
Relative Bioavailability of Intravenous GTX-104 Compared to Oral Nimodipine Capsules in Healthy Subjects
Lead Sponsor:
Grace Therapeutics Inc.
Conditions:
Aneurysmal Subarachnoid Hemorrhage
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 fo...
Eligibility Criteria
Inclusion
- Subject had a body mass index between 18 and 32 kg/m2, inclusive.
- Subject was in good general physical health as determined by absence of clinically significant (CS) medical or psychiatric history, physical examination findings, vital signs, clinical laboratory evaluations, and 12-lead ECG measurements.
Exclusion
- History or presence of clinically significant medical illness, including, but not limited to, cardiovascular, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, psychiatric, renal, hepatic, chronic respiratory, or gastrointestinal disease, that could have interfered with the interpretation of the study.
- Had current or recent (within 6 months) history of gastrointestinal disease or any surgical or medical condition (eg, Crohn's or liver disease) that could potentially alter the absorption, metabolism, or excretion of the study drug.
Key Trial Info
Start Date :
August 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2022
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT05418348
Start Date
August 26 2021
End Date
February 24 2022
Last Update
August 31 2023
Active Locations (1)
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1
Clinical Research Unit
Montreal, Canada