Effect of Oral Sildenafil With Digital Therapeutic Iontophoresis of Sodium Nitroprussiate in Healthy Volunteers

University Hospital, Grenoble40 enrolled

Overview

Iontophoresis is a employed to facilitate drug absorption without systemic effect. This study investigates cutaneous microcirculation when we associate sildenafil per os with SNP via iontophoresis.

The main outcome is the proof of concept of effect of systemic absorption sildenafil on cutaneous microcirculation associated with SNP iontophoresis.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

sildenafilDRUG

systemic absorption of sildenafil

nitroprussiate iontophoresisDRUG

nitroprussiate iontophoresis

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age over 18 * No significant medical history Exclusion Criteria: * Age under 18 * Period of exclusion for an other study * Pregnancy * Breast feeding * Severe disease * Cigarette smoking

Locations (1)

Clinical Researsh Centre

Grenoble, Isere, France

Outcomes

Primary Outcomes

variation of conductance of nitroprussiate iontophoresis associated with oral sildenafil

Time frame: one hour

Secondary Outcomes

To assess the effect of oral sildenafil (50 mg and 100 mg) on skin microvascular reactivity to local cooling, on the forearm and the finger

Time frame: one hour

Data from ClinicalTrials.gov

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