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First received: June 05, 2023

Clinical Trial: Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Smallpox

Study Type: INTERVENTIONAL


Official Title: A Phase 1, Open-label, Single-dose, Randomized, Two-period, Crossover Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adult Participants

Brief Summary: The goal of this clinical trial is to evaluate whether both Form H and Form II, 100mg brincidofovir tablets are bioequivalent, when given under fasting conditions in healthy adults.Participants will be randomized to each receive one tablet of Form H and one tablet of Form II,14 days apart and undergo pharmacokinetic testing pre-dose and post-dose to evaluate safety.This is an open-label, single-dose, randomized, two-period, crossover study.

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