Safety and Pharmacokinetic Comparison of Sildenafil ODF and FCT Formulations in Healthy Korean Volunteers
This study has been completed.
Seoul Pharma Co., Ltd.
First Posted: January 17, 2013
Last Update Posted: January 17, 2013
Information provided by (Responsible Party):
Seoul Pharma Co., Ltd.
This study investigates safety and pharmacokinetic comparison of Seoul Pharma's orally disintegrating film (ODF) formulation of sildenafil (test formulation) and Pfizer's "Viagra® (sildenafil)" Film Coated Tablet (FCT) formulation (reference formulation) in healthy volunteers.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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Further study details as provided by Seoul Pharma Co., Ltd.:
Primary Outcome Measures:
- AUC [ Time Frame: 0 (predose), 0.017, 0.05, 0.117, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours after the dose ]
Secondary Outcome Measures:
- Cmax [ Time Frame: 0 (predose), 0.017, 0.05, 0.117, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours after the dose ]
|Study Start Date:||September 2011|
|Study Completion Date:||December 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
A single-dose of ODF and FCT formulations of sildenafil given orally in a fasted state (dose: 50mg), with a 7-day washout period between the formulations.
A single-dose of ODF and FCT formulations of sildenafil given orally in a fasted state (dose: 100mg), with a 7-day washout period between the formulations.
- Background: An orally disintegrating film (ODF) formulation of sildenafil was recently developed in Korea. This formulation is expected to enhance the dosing convenience and increase patient compliance while yielding pharmacokinetic profiles comparable to the conventional film coated tablet (FCT) formulation.
- Objective: The goal of present study is to compare the pharmacokinetic (PK) profiles of a newly developed ODF formulation with a FCT formulation of sildenafil in healthy Korean male volunteers.
- Methods: This is a randomized, open-label, 2-period cross-over, single-dose study conducted in 2 parts. Eligible subjects were healthy male volunteers between the ages of 20 and 50 years and within 20% of their ideal body weight, and are equally divided into parts 1 and 2. Each subject will be received a single -dose of ODF and FCT formulations of sildenafil orally in a fasted state (part 1, 50mg; part 2, 100mg), with a 7-day washout period between the formulations. Blood samples are collected up to 24 hours. Pharmacokinetic parameters are determined for sildenafil and its active metabolite (N-desmethyl sildenafil). Adverse events will be also evaluated based on subject interviews and physical examinations.
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