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This is a single-center, two-period, randomized, open-label, crossover pharmacokinetic (PK) study in healthy adult volunteers to evaluate dose proportionality of diazepam nasal spray using two dose levels
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| diazepam nasal spray (AB) | Experimental | Each subject will receive two single doses of investigational product (DL1, DL2) with a 14-day washout between the doses. The order in which the doses are administered will be randomized, with subjects assigned to 1 of 2 treatment sequences: DL1 (A) followed by DL2 (B), or the reverse order (BA). |
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| diazepam nasal spray (BA) | Experimental | Each subject will receive two single doses of investigational product (DL1, DL2) with a 14-day washout between the doses. The order in which the doses are administered will be randomized, with subjects assigned to 1 of 2 treatment sequences: DL1 (A) followed by DL2 (B), or the reverse order (BA). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diazepam nasal spray | Drug | diazepam nasal spray at two dose levels (DL). One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum measured plasma concentration (Cmax) | within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose | |
| Area under the concentration curve from time 0 to the concentration at 24 hours (AUC0-24) | within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose | |
| Area under the concentration curve from time 0 to infinity (AUCinf) | within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose | |
| Apparent total body clearance of drug from plasma (CL/F) | within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events (AEs) including serious AEs | up to 21 days | |
| Change in focused nasal exam | within 30 minutes prior to dosing and at specified time points up to 24 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Squillacote, MD | Acorda Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site #001 | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| D003975 | Diazepam |
| D059085 | Nasal Sprays |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Taste change questionnaire | If patient reports a change in taste associated with diazepam nasal spray, questionnaire to be completed by research staff. | from 5 minutes up to 24 hours post-dose |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000336 | Aerosols |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |