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

• Sponsor: Hanmi Pharmaceutical Company Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01514903
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: HIP0908; Drug: viagra	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: viagra,anti-erectile dysfunction agent	Drug: viagra; single dose, cross over
Experimental: HIP0908	Drug: HIP0908; SINGLE DOSE , CROSS OVER

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sinchon Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanmi Pharmaceutical Company Limited
• ClinicalTrials.gov Identifier: NCT01514903
• Other Study ID Numbers: HM-SIL-102
• First Posted: Jan 23, 2012
• Last Update Posted: Oct 12, 2016
• Last Verified: Oct 1, 2016

• Keywords provided by Hanmi Pharmaceutical Company Limited: anti erectile dysfunction agent
• Additional relevant MeSH terms: Erectile Dysfunction; Sildenafil Citrate

Study Results

No Results Posted as of Oct 12, 2016