A Single-Center, Open-Label, 3-Way Crossover Trial to Determine the Pharmacokinetic and Pharmacodynamic Interaction Between Nebivolol and Valsartan in Healthy Volunteers at Steady State

30 healthy adults aged 18-45 years (mean age 32.6, 50% female), nonsmokers for at least 2 years, BMI 18-30 kg/m2, and resting pulse rate 50-100 bpm. Key exclusions: contraindication to beta-blockers or ARBs, resting SBP <=90 or >=140 mm Hg, DBP <50 or >=90 mm Hg.

Nebivolol 20 mg and valsartan 320 mg combination administered orally once daily for 7 days

Nebivolol 20 mg oral once daily alone, and valsartan 320 mg oral once daily alone (administered in a 3-way crossover design with 7-day washouts)

Pharmacokinetic parameters (AUC0-τ,ss, Cmax,ss, Tmax,ss) and pharmacodynamic interactions (changes in blood pressure, pulse rate, plasma angiotensin II, plasma renin activity, 24-hour urinary aldosterone) at steady state (day 7)surrogate