Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT04994860
Brief Summary:
The purpose of this study is:
* To assess the effect of BIA 5 1058 400 mg on the pharmacokinetics (PK) of sildenafil.
* To assess the effect of sildenafil on the PK of BIA 5-1058.
Detailed Description:
This study was an open label, three period, fixed sequence study in healthy male and female subjects performed under fasting conditions at a single study center.
The study comprised:
* Screening during Days -28 to -2 (both inclusive).
* Three treatment periods separated by a washout period of at least 10 days.
Duration of Treatment:
The duration of participation for each subject was approximately 2 months and 3 weeks (including the screening period).
Study:
NCT04994860
Study Brief:
Protocol Section:
NCT04994860