Hypertension Clinical Trial
Official title:
A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453 in Healthy Male Volunteers
The purpose of this study is to assess the tolerability of BIA 5-453 after six multiple rising dose regimens of BIA 5-453.
Two centres, double-blind, randomised, placebo-controlled study of six dosage regimens of
BIA 5-453 in six groups of healthy male subjects.
In each group, the study consisted of a 10-day multiple-dose period. Progression to the next
dose level only occurred if the previous dose level was considered to be safe and well
tolerated. An appropriate interval separated the investigation of doses to permit a timely
review and evaluation of safety data (including plasma exploratory pharmacokinetics) prior
to proceeding to a higher dose level.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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