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To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers

Healthy Clinical Trial

Official title:
An Open Label, Randomized, Single Dose, Cross Over Study to Evaluate Food Effects on Relative Bioavailability of RP6530 Administered in Fasting and Fed Conditions in Healthy Volunteers

Clinical Trial Summary

This is a single centre, open label, randomized, two-treatment, two-period, two-sequence, single dose crossover food effect study in 18 subjects. The subjects will receive the study medication under either fed or fast during each treatment period.

Clinical Trial Description

The present study will be conducted in healthy male volunteers. A single oral dose will be administered to the subject in each treatment period (under either fasting or fed state). Each treatment period will be separated by at least 7 calendar days. Post dose PK blood samples will be collected in each treatment period to evaluate the food effect on bioavailability of RP6530. The safety and tolerability of single dose will also be evaluated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02690727
Study type Interventional
Source Rhizen Pharmaceuticals SA
Contact
Status Completed
Phase Phase 1
Start date February 2016
Completion date March 2016
View Details
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