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A Formulation Bridging and Food Effect Study of PBI-200 in Healthy Volunteers

Food Effect Clinical Trial

Official title:
A Single-Dose, Open-Label, Two-Part, Randomized, Crossover Formulation Bridging and Food Effect Study to Assess the Effect of Formulation and Food on the Absorption and Bioavailability of PBI-200 in Normal Healthy Volunteers

Clinical Trial Summary

This is a single-dose, two-part, crossover formulation bridging and food effect study to assess the effect of formulation and food on the absorption and bioavailability of PBI-200 in normal, healthy volunteers.

Clinical Trial Description

This is a single-dose, two-part crossover formulation bridging (Part A) and tablet food effect (Part B) study in normal, healthy volunteers. Part A will be conducted to evaluate the pharmacokinetics (PK) and relative bioavailability of 3 formulations of PBI-200; each volunteer will serve as their own control. In Part B, PBI-200 tablets will be dosed under fasting and fed (low-fat and high-fat meals) conditions to evaluate the effect of food on the PK of PBI-200. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05690932
Study type Interventional
Source Pyramid Biosciences
Contact
Status Completed
Phase Phase 1
Start date February 24, 2022
Completion date May 23, 2022
View Details
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