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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 is a Phase 1 study that has completed, run by Tonix Pharmaceuticals. The registered enrollment target is 20 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07464535
The ClinicalTrials.gov registry entry for NCT07464535 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tonix Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TNX-102 SL is the first listed.
NCT07464535 reports 0 study locations.
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.
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