Trial reportClinical pharmacology in drug development2020
Evaluation of Pharmacokinetics and Dose Proportionality of Diazepam After Intranasal Administration of NRL-1 to Healthy Volunteers.
Trial report in Clinical pharmacology in drug development, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed.
- Safety of Diazepam Nasal Spray in Pediatric Patients With Developmental Epileptic Encephalopathies: Results From a Long-term Phase 3 Safety Study.Journal of child neurology · 2023Trial
- Trial
- Consistent safety and tolerability of ValtocoEpilepsia open · 2021Trial
- Bioavailability and safety of diazepam intranasal solution compared to oral and rectal diazepam in healthy volunteers.Epilepsia · 2020Trial
- Efficacy and safety of diazepam nasal spray in Japanese Pediatric patients with or at risk for status epilepticus: a phase 3, Multicenter, open-label clinical trial.Epilepsy & behavior reports · 2026Article
- Leveraging in vitro Tumor Cell Killing and Cytokine Release to Predict Cytokine Release Syndrome Associated with CD3 T-cell Bispecifics in Oncology: a Retrospective Analysis.The AAPS journal · 2025Article
- Treatment of Seizure Clusters in Epilepsy: A Narrative Review on Rescue Therapies.Neurology and therapy · 2023Review
- Review
- Article
- A comparative evaluation of cardiac and neurological safety status of two commonly used oral hypoglycaemic agents in T2-DM Swiss albino mice model.Metabolism open · 2022Article
- Overcoming the challenges of developing an intranasal diazepam rescue therapy for the treatment of seizure clusters.Epilepsia · 2021Article
- A Short Review on the Intranasal Delivery of Diazepam for Treating Acute Repetitive Seizures.Pharmaceutics · 2020Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
NRL-1 is a novel intranasal formulation of diazepam that is being evaluated as rescue medication in patients with epilepsy who experience bouts of increased seizure activity despite stable regimens of antiepileptic drugs. This phase 1, open-label, randomized, crossover study in healthy adult volunteers consisted of 3 single-dose periods (5, 10, and 20 mg) followed by a 2-dose period (2 × 10 mg) with a minimum 28-day washout between treatments. Blood samples were taken at prespecified time points after intranasal dosing, and bioanalytic analysis of diazepam and nordiazepam was conducted using a validated liquid chromatography-tandem mass spectrometry method. Plasma pharmacokinetic parameters were summarized using descriptive statistics, and dose proportionality (peak concentration [C
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.