Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A (GTX-104 IV, Test): | Experimental | Nimodipine was administered by infusion over 72 hours. |
|
| Treatment B (NIMOTOP, RLD): | Experimental | Nimodipine capsules (RS) administered orally with 240 mL of water at a dose level of 60 mg (two 30 mg capsules) q4h for 72 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GTX-104 | Drug | new formulation of nimodipine injection for IV infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax Day 1 | Maximum concentration | Day 1 for the first dose (8:00 AM dose) |
| AUC (AUCDay 3, 0-24hr) | Area under the concentration-time curve | Day 3 from 8:00 AM to 8:00 AM from 0 to 24 hr |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax Day 3 across all 6 doses | Maximum concentration across all doses | Day 3 |
| Absolute bioavailability (F) Day 3 | the ratio of geometric LSmeans with corresponding 90% confidence interval calculated from the exponential of the difference between the Treatment-1 and Treatment-2 for the ln-transformed parameters Cmax Day3 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric Sicard, MD | Clinical Research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Unit | Montreal | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009553 | Nimodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nimodipine Capsules |
| Drug |
Nimodipine capsules (reference formulation) |
|
| Day 3 |
| Total body clearance of the drug from plasma after IV infusion (CL) Day 3 | (Dosedaily/AUCDay3,0-24) | Day 3 from 8:00 AM to 8:00 AM from 0 to 24 h |
| Apparent total body clearance of the drug from plasma after oral administration (CL/F) Day 3 | Dosedaily/AUCDay 3 0-24 | Day 3 from 8:00 AM to 8:00 AM from 0 to 24 h |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009539 |
| Nicotinic Acids |