Key result
Irbesartan demonstrated dose-proportional pharmacokinetics up to 600 mg and was well tolerated at doses up to 900 mg daily in healthy men.
Why the study?
What are the safety, pharmacokinetics, and pharmacodynamics of single and multiple doses of irbesartan in healthy men?
Population
48 healthy men
Comparison
Irbesartan at doses of 150 mg, 300 mg, 600 mg… vs Placebo
Design
RCT, randomized to receive irbesartan at doses of 150 mg, 300 mg, 600 mg, or…
Follow-up
11 days
Authors
Loading...
Supports dose escalation trials in patients; extends tolerability and dose-proportional PK data to 900 mg in healthy subjects.
RCT (n=48)
Double-blind
sequential, dose-ascending
No
What are the safety, pharmacokinetics, and pharmacodynamics of single and multiple doses of irbesartan in healthy men?
Irbesartan exhibits dose-proportional pharmacokinetics up to 600 mg and is well tolerated at doses up to 900 mg daily in healthy men.
Marino et al. (1998) conducted an RCT in Healthy subjects (n=48). Irbesartan vs. Placebo was evaluated on Safety, pharmacokinetics, and pharmacodynamics. Irbesartan demonstrated dose-proportional pharmacokinetics up to 600 mg and was well tolerated at doses up to 900 mg daily in healthy men.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: