Bioavailability and Safety of TNX-601 vs Stablon in Healthy Subjects
Research type
Research Study
Full title
A Phase 1 formulation selection study comparing the bioavailability and safety of TNX-601 (tianeptine oxalate) immediate release and modified release tablets with the reference product Stablon® (tianeptine sodium) in male and female subjects
IRAS ID
257223
Contact name
Litza McKenzie
Contact email
Sponsor organisation
Tonix Pharma Ltd.
Eudract number
2019-001366-14
Duration of Study in the UK
0 years, 3 months, 13 days
Research summary
The Sponsor Tonix Pharma Ltd. is developing a new formulation (recipe) of the test medicine, tianeptine, for the potential treatment of post-traumatic stress disorder (PTSD). PTSD is a long-term trauma and stressor-related disorder caused by very stressful, frightening or distressing events. Traumatic situations that can cause PTSD involve people being exposed to actual or threatened death, serious injury, or sexual violence. This can either happen to oneself or by observing it happening to another person. PTSD can develop immediately after the traumatic event or it can occur weeks, months or even years later.\n\nThe aim of the study is to develop a new formulation of tianeptine that will hopefully only need to be taken once a day. Current marketed products are taken 3 times a day. The study will look at how new formulations (immediate and modified release formulations) are taken up and broken down by the body compared to an already marketed formulation. The safety and tolerability of the new formulations will be investigated. The effects of taking a selected formulation with food may also be investigated.\n\nThe study will consist of 6 study periods (visits) involving up to 12 healthy male and female volunteers. In each Period, volunteers will receive a single dose of medicine following an overnight fast, or after a high-fat breakfast. Volunteers will be admitted to the clinical unit on the evening of Day-1 and will be discharged on the morning of Day 3. There will be a minimum of 7 days between each dose of medicine. During each Period, blood samples will then be collected at regular intervals.
REC name
Wales REC 2
REC reference
19/WA/0205
Date of REC Opinion
30 Jul 2019
REC opinion
Further Information Favourable Opinion