Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07464535
Brief 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.
Study:
NCT07464535
Study Brief:
Protocol Section:
NCT07464535