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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Erectile Dysfunction

Treatments: Drug: HIP0908; Drug: viagra

Study type: Interventional

Funder types: Industry

Identifiers

NCT01514903

HM-SIL-102

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

54 participants in 2 patient groups

viagra,anti-erectile dysfunction agent

Active Comparator group

Treatment:

Drug: viagra

HIP0908

Experimental group

Treatment:

Drug: HIP0908