Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
NCT ID:
NCT06393127
Pre Assignment Details:
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Screening procedures also included physical examination, check of vital signs, electrocardiogram, safety laboratory, demographics, relevant medical history, concomitant therapy. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Recruitment Details:
This was a open-label, randomised, single-dose, two-way crossover trial in healthy subjects to compare the test treatment (T - nerandomilast \[BI 1015550\] Formulation C2) to the reference treatment (R - nerandomilast Formulation C1, as the phase 3 formulation). Subjects were randomly allocated to the 2 treatment sequences (T-R or R-T), and there was a washout period of at least 10 days between the administration of each treatment.
Study:
NCT06393127
Study Brief:
Results Section:
NCT06393127