NCT02266940

Relative Bioavailability DS-1971a Suspension and Tablets and Food Effect on DS-1971a Tablets

A Phase 1, Open Label, Randomised, Single Dose, Three Way Crossover Study to Explore the Relative Bioavailability of DS 1971a Given as a 200 mg Tablet Formulation and a 200 mg Oral Suspension, and to Explore the Effects of Administration With a High Fat Meal on the Relative Bioavailability of the Tablet Formulation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is an open label, randomised, 3 treatment, 3 period crossover study. This study is designed to assess the relative bioavailability of DS 1971a from a tablet formulation and a reconstituted oral suspension and the effect of a high fat meal on the relative bioavailability of DS 1971a from the tablet formulation.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DS-1971a suspension	DS 1971a will be supplied as a powder or crystals and prepared at the study site for administration as an oral suspension with a taste masking agent.
DRUG	DS-1971a tablet	A 200 mg DS 1971a tablet for oral administration

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-10-17
• Last updated: 2018-12-24

Locations

1 site across 1 country: United Kingdom