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

Phase 1

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: HIP0908; Drug: viagra

• Registration Number: NCT01514903
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-23
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-11
• Last Update Posted: 2016-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HIP0908	HIP0908	-
viagra,anti-erectile dysfunction agent	viagra	-

Primary Outcome Measures

Name	Time	Method
AUC and Cmax of sildenafil	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

Trial Locations

Locations (1)

Sinchon Severance Hospital; 🇰🇷 Seoul, Korea, Republic of