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A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects

Healthy Clinical Trial

Official title:
Interventional, Open-label, Two-part, Partly-randomized Study Investigating the Pharmacokinetic Properties, Absolute Bioavailability, Food Effect, and Intra-subject Variability of up to 5 Prototype Modified-release Tablet Formulations of Lu AF11167 in Healthy Subjects

Clinical Trial Summary

The purpose of this study is to investigate the extent to which Lu AF11167 enters the bloodstream following tablet intake and the influence of food on uptake in healthy men and women

Clinical Trial Description

This study will be split into Part A and Part B. Part A will happen first and will look at new tablet formulations of the test medicine compared to a previously known formulation (reference tablet). The results from Part A of the study will be used to decide which formulation will be tested in Part B of the study. Part B of the study will look at the food effect, variability between participants, and absolute bioavailability of the test medicine i.e. how much of the test medicine is taken up by the body when dosed by mouth compared to when dosed once by injection directly into the vein. Safety and tolerability will be assessed throughout the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04104503
Study type Interventional
Source H. Lundbeck A/S
Contact
Status Completed
Phase Phase 1
Start date September 17, 2019
Completion date April 9, 2020
View Details
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