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NCT06393127Not yet recruiting

A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body

Bioequivalence of the BI 1015550 High Dose Formulation C2 and the BI 1015550 High Dose Formulation C1 (Phase 3 Formulation) Following Oral Administration in Healthy Subjects (an Open-label, Randomised, Single-dose, Two-way Crossover Trial)
Boehringer IngelheimPhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Healthy
Drug/Device/Intervention
BI 1015550 Formulation C2
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Boehringer Ingelheim
Timeline & enrollment
Phase
Phase 1
Start date
May 07, 2024
End date
Aug 30, 2024
Enrollment
64 participants
Primary outcome

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz),Maximum measured concentration of the analyte in plasma (Cmax)

Summary

The main objective of this trial is to establish the bioequivalence of the BI 1015550
 Formulation C2 (Test, T) and the BI 1015550 Formulation C1 (Reference, R), following a single
 oral dose administration.

ICD-10 classifications
ObesitySeeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmfulHealthy person accompanying sick personLifestyle-related conditionMalnutrition
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06393127
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06393127 through Pure Global AI's free database. This Phase 1 trial is sponsored by Boehringer Ingelheim and is currently Not yet recruiting. The study focuses on Healthy. Target enrollment is 64 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.