This is a Phase 1, open-label, single-ascending-dose study evaluating the safety, tolerability, and pharmacokinetics (PK) of Viaca - a fixed-dose oral combination of sildenafil (a PDE5 inhibitor) and cabergoline (a dopamine D2 agonist) - versus sildenafil monotherapy and cabergoline monotherapy in healthy adult male volunteers. Approximately 30 participants are enrolled across 5 sequential cohorts (6 each). Each participant receives a single oral dose. The combination targets erectile dysfunction through both vascular and neuroendocrine pathways, aiming for efficacy at lower component doses.
Inclusion Criteria:
Exclusion Criteria:
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Single oral dose of Viaca (sildenafil 25 mg / cabergoline 0.25 mg; one low-dose tablet) in 6 healthy male participants.
Single oral dose of Viaca (sildenafil 50 mg / cabergoline 0.5 mg; one high-dose tablet
Single oral dose of Viaca (sildenafil 75 mg / cabergoline 0.75 mg; one low + one high tablet
Single oral dose of sildenafil 50 mg (two 25 mg tablets).
Single oral dose of cabergoline 0.5 mg (one 0.5 mg tablet).
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