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NCT07464535 · ClinicalTrials.gov registry record · Phase 1
A Single-Dose, Randomized, Open-Label, 2-Way Crossover Study to Evaluate the Dose-Proportionality, Safety, and Tolerability of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) in Healthy Japanese and Chinese Subjects
A Phase 1 study, sponsored by Tonix Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT07464535: Completed Phase 1 study, sponsored by Tonix Pharmaceuticals.
NCT07464535 is a Phase 1 study that has completed, run by Tonix Pharmaceuticals. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07464535, a Phase 1 study, has completed, sponsored by Tonix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Primary Objectives: To characterize the pharmacokinetic (PK) profile and dose proportionality of cyclobenzaprine and norcyclobenzaprine following administration of 2.8 mg and 5.6 mg of TNX-102 SL (either one or two 2.8 mg tablets) under fasting conditions in Japanese and Chinese subjects. To retrospectively compare PK data from the Japanese and Chinese study subjects with existing data from a non-Asian Phase 1 study investigating the administration of 2.8 mg and 5.6 mg of TNX-102 SL under fasting conditions. Secondary Objective: To assess the safety and tolerability of TNX-102 SL (2.8 mg and 5.6 mg) in healthy Japanese and Chinese subjects.
Interventions
- DRUG TNX-102 SL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-03-18 |
| Est. Completion | 2022-04-30 |
| Phase | Phase 1 |
What the finished NCT07464535 record still lists
NCT07464535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which TNX-102 SL is the first listed.
NCT07464535 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07464535 about?
NCT07464535 is a clinical study titled "A Single-Dose, Randomized, Open-Label, 2-Way Crossover Study to Evaluate the Dose-Proportionality, Safety, and Tolerability of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) in Healthy Japanese and Chinese Subjects". Primary Objectives: To characterize the pharmacokinetic (PK) profile and dose proportionality of cyclobenzaprine and norcyclobenzaprine following administration of 2.8 mg and 5.6 mg of TNX-102 SL (either one or two 2.8 mg tablets) under fasting conditions in Japanese and Chinese subjects. To retrosp...
What is the current status of trial NCT07464535?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2022-03-18. Estimated completion is 2022-04-30.
What interventions are being tested in trial NCT07464535?
The interventions under investigation include: TNX-102 SL (DRUG).
Who is sponsoring clinical trial NCT07464535?
This trial is sponsored by Tonix Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07464535's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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