NCT03886272

A Study in Healthy Men and Women to Test if Taking Different Formulations of BI 730357 Tablets Influences the Amount of BI 730357 in the Blood

Relative Bioavailability of Intended Commercial Formulations (iCF) of BI 730357 Versus BI 730357 Trial Formulation 1 and Bioavailability Comparison of Three Different iCF Batches Following Oral Administration in Healthy Subjects (an Open-label, Single-dose, Randomised, 2-way and 3-way Crossover Trial)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The main objective of Trial Parts 1 and 2 is to investigate the relative bioavailability of two tablet strengths (low dose and high dose) of the intended Commercial Formulation of BI 730357 (Test, T) versus with the corresponding tablet strengths of Trial Formulation 1 (Reference, R). The main objective of Trial Part 3 is to investigate the relative bioavailability of two iCF side batches of BI 730357 with coarse milled Active pharmaceutical ingredient (API)(Test coarse milled, Tc) and unmilled API (Test unmilled, Tu), respectively, versus the final iCF batch of BI 730357 with regularly milled API (Reference, R).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 730357 (Test)	tablet
DRUG	BI 730357 (Reference)	tablet

Timeline

• Start date: 2019-04-11
• Primary completion: 2019-06-21
• Completion: 2019-06-21
• First posted: 2019-03-22
• Last updated: 2023-07-17
• Results posted: 2023-07-17

Locations

1 site across 1 country: Germany