CRS Clinical Research Services Mannheim GmbH
Mannheim, 68167, Germany
NCT Number: NCT06408870
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.
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Notify Me18 year–50 year
All sexes
Interventional
Phase 1
Mannheim, 68167, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Highly effective methods of contraception include:
Exclusion criteria
Participants received two formulations of nerandomilast separated by a washout period
Other names: Nerandomilast
Time frame: Within 3 hours (hrs) prior to and at 15minutes (min), 30min, 45min, 1hrs, 1:15hrs, 1:30hrs, 1:45hrs, 2hrs, 2:30hrs, 3hrs, 3:30hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 34hrs, 48hrs, 58hrs, 72hrs, 96hrs, 120hrs, and 144hrs after nerandomilast intake.
Area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
The statistical model applied was an analysis of variance (ANOVA), with 'subjects within sequence' as a random effect and 'sequence,' 'period,' and 'treatment' as fixed effects.
Time frame: Within 3 hours (hrs) prior to and at 15minutes (min), 30min, 45min, 1hrs, 1:15hrs, 1:30hrs, 1:45hrs, 2hrs, 2:30hrs, 3hrs, 3:30hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 34hrs, 48hrs, 58hrs, 72hrs, 96hrs, 120hrs, and 144hrs after nerandomilast intake.
Maximum measured concentration of nerandomilast in plasma (Cmax) is presented. The statistical model applied was an analysis of variance (ANOVA), with 'subjects within sequence' as a random effect and 'sequence,' 'period,' and 'treatment' as fixed effects.
Time frame: Within 3 hours (hrs) prior to and at 15minutes (min), 30min, 45min, 1hrs, 1:15hrs, 1:30hrs, 1:45hrs, 2hrs, 2:30hrs, 3hrs, 3:30hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 34hrs, 48hrs, 58hrs, 72hrs, 96hrs, 120hrs, and 144hrs after nerandomilast intake.
Area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented.
The statistical model applied was an analysis of variance (ANOVA), with 'subjects within sequence' as a random effect and 'sequence,' 'period,' and 'treatment' as fixed effects.
Boehringer Ingelheim
Industry
Bioequivalence of the BI 1015550 Low Dose Formulation C2 and the BI 1015550 Low Dose Formulation C1 (Phase 3 Formulation) Following Oral Administration in Healthy Subjects (an Open-label, Randomised, Single-dose, Two-way Crossover Trial)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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