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
Abstract
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.
Conditions: Pulmonary Arterial Hypertension.
Primary outcome: Cmax - Maximum observed concentration (for BIA 5-1058); Tmax - Time corresponding to occurrence of Cmax (for BIA 5-1058); T½ - Apparent terminal elimination half life (for BIA 5-1058); Cmax,ss - Maximum observed concentration at steady state (for sildenafi); Tmax,ss - Time corresponding to occurrence of Cmax,ss at steady state (for sildenafi); T½,ss - Apparent terminal elimination half-life at steady state (for sildenafi).
Enrollment: 20 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 20 participants or records.
Read the paper
Related studies
- Drug repositioning: a brief overview
- Cyclic nucleotide phosphodiesterases in Drosophila melanogaster
- Time-resolved in silico modeling of fine-tuned cAMP signaling in platelets: feedback loops, titrated phosphorylations and pharmacological modulation
- Current View on Green Tea Catechins Formulations, Their Interactions with Selected Drugs, and Prospective Applications for Various Health Conditions
- In silico Structure-based Identification of Novel Acetylcholinesterase Inhibitors Against Alzheimer’s Disease
- Development and In Vitro Evaluation of Controlled Release Viagra® Containing Poloxamer-188 Using Gastroplus™ PBPK Modeling Software for In Vivo Predictions and Pharmacokinetic Assessments
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.