Healthy Volunteers Clinical Trial
Official title:
A Randomized, Single-dose, Open-label, Single-center, Crossover Study to Assess the Relative Bioavailability and Safety of Different Formulations of AZD4831 in Fasted State in Healthy Volunteers.
A study to assess the relative bioavailability and safety of different formulations of AZD4831 in fasted state in healthy volunteers.
This study will be a randomized, open-label, 2-period, 2-treatment, single-dose, single-center, crossover study conducted at a single Clinical Unit. A total of 30 healthy male and female participants will be randomized to ensure that at least 26 participants are evaluable . The study will comprise of: - A Screening Period of maximum 28 days. - Period 1: single oral dose AZD4831 Formulation A or B on Day 1. - Period 2: single oral dose AZD4831 Formulation A or B on Day 1. - A final Follow-up Visit after the last administration of Investigational medicinal product (IMP) (14 days [+ 3 days] post final dose). There will be a minimum washout period of at least 14 days from the first dose of AZD4831. Participants will receive single doses of AZD4831 (2 different formulations) on 2 occasions under fasted conditions. Participants will be given the following treatments and randomly assigned to the treatment sequence(s): AB, BA - Treatment 1 (Reference), AZD4831 Formulation A, oral dosage form), fasted. - Treatment 2 (Test), AZD4831 Formulation B, oral dosage from), fasted. ;
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