In short
Clinical trials are investigating SOFTISAN 378 in healthy adults. The study is looking at whether it affects sleep quality after late evening exercise and is measuring sleep efficiency. This helps researchers learn about its effects in a small Phase 2 study.
Key points
- Clinical trials are studying SOFTISAN 378 in healthy individuals after late evening exercise. The trial is in Phase 2 and is authorized. It is a small interventional study with 20 planned participants. Researchers are comparing SOFTISAN 378 with cannabidiol and focusing on sleep efficiency. The main question is whether sleep changes between study sessions.
Trial overview
The available clinical trial is titled The effect of CBD on sleep quality following late evening exercise and is studying SOFTISAN 378 in healthy individuals.
The study is interventional, which means researchers give the study treatments and then observe what happens.
The trial is authorised and planned for 20 participants.
Who can participate
This study is designed for healthy individuals.
The source data does not give more details about age limits, sex, or other entry rules, so only the broad target group can be confirmed from the trial record.
What is being measured
The main outcome is sleep efficiency, which is the time asleep divided by the time in bed.
Researchers want to see changes in sleep efficiency between different sessions, so they can compare how sleep is affected under the study conditions.
The brief summary says the study is investigating the effect of CBD on sleep efficiency after late evening exercise.
Study design and phase
This is a Phase 2 trial.
Phase 2 studies are early research studies that look more closely at whether a treatment may work and continue to collect safety information in a small group.
The interventions listed in the record are SOFTISAN 378, given orally at 1200 mg, and cannabidiol, given orally at 400 mg.
The record does not provide more details about the study schedule, but it does show that the trial compares different sessions.
What this study may help researchers learn
This trial may help researchers understand whether SOFTISAN 378 is linked to changes in sleep after late evening exercise in healthy people.
Because the study is small, with only 20 planned participants, it is meant to give early information rather than final proof.
The study also uses cannabidiol as a comparison treatment, which helps researchers compare results between sessions.