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A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body - Trial NCT06393127

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.

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NCT06393127
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06393127
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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)

Study Focus

Healthy

BI 1015550 Formulation C2

Interventional

drug

Sponsor & Location

Boehringer Ingelheim

Timeline & Enrollment

Phase 1

May 07, 2024

Aug 30, 2024

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

Obesity
Seeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmful
Healthy person accompanying sick person
Lifestyle-related condition
Malnutrition

Data Source

ClinicalTrials.gov

NCT06393127

Non-Device Trial