Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers

Hanmi Pharmaceutical Company Limited54 enrolled

Overview

This is a single dose open-label comparative pharmacokinetic study to assess the pharmacokinetic characteristics of sildenafil between HIP0908 (chewable tablet) and Viagra (tablet) in healthy male subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Erectile Dysfunction

Interventions

HIP0908DRUG

SINGLE DOSE , CROSS OVER

viagraDRUG

single dose, cross over

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * age between 20 and 45 * weight : over 55kg and 18.5 \< BMI, 25.0 * have to give their consent to participating clinical trial by oneself Exclusion Criteria: * has a medical history of hypersensitivity to drug including PDE5 inhibitor and QTc \> 430ms or uncontrolled arrhythmia

Locations (1)

Sinchon Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

AUC and Cmax of sildenafil

Time frame: Pre-dose (0h), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hr post-dose

Data from ClinicalTrials.gov

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