Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 4:42 AM
Study NCT ID:
NCT04994860
Status:
COMPLETED
Last Update Posted:
2021-08-06
First Post:
2021-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Sildenafil
Sponsor:
Bial - Portela C S.A.
Organization:
Study Overview
Official Title:
An Open-Label, Three Period, Fixed Sequence Study to Assess the Effect of a Single Dose of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Sildenafil in Healthy Subjects Under Fasting Conditions
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-000224-99 | EUDRACT_NUMBER | None | View |