CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 43 enrolled
Drug / intervention
BI 730357 (Test) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03886272
NCT03886272Phase 1Completed
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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)

Boehringer Ingelheim·interventional·Posted Mar 22, 2019·Updated Jul 17, 2023

In Brief

A Phase 1 clinical trial evaluating BI 730357 (Test) and BI 730357 (Reference) for Healthy. Completed, enrolled 43 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedMar 22, 2019
Enrollment StartApr 11, 2019
Primary CompletionJun 21, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.3 years ago

Interventions

BI 730357 (Test)drug

tablet

BI 730357 (Reference)drug

tablet