Study to Evaluate Pharmacokinetics, Relative Bioavailability, Palatability of Obefazimod Minitablet Formulation
Recruiting
Phase 1
Interventional Study
Healthy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 55
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 44 (estimated)
- Sponsor
- Abivax S.A. · Industry
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About This Trial
The sponsor is developing a pediatric minitablet formulation as part of the overall pharmaceutical development strategy. In vitro dissolution and physiological-based bio-pharmaceutics modelling and simulation have been used to guide the development of the mini-tablet formulation to match the PK exposure of the adult capsule formulation. The study aims to investigate the relative bioavailability of…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Aged 18 to 55 years inclusive at the time of signing informed consent
* Must agree to adhere to the contraception requirements.
* Healthy male or non-pregnant, non-lactating female participants according to the assessment of the investigator, as based on a complete medical his…
Contacts