Safety and Pharmacokinetic Comparison of Sildenafil ODF and FCT Formulations in Healthy Korean Volunteers
|ClinicalTrials.gov Identifier: NCT01769638|
Recruitment Status : Completed
First Posted : January 17, 2013
Last Update Posted : January 17, 2013
Seoul Pharma Co., Ltd.
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: SPO1101 Drug: SPO1101D||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2011|
|Primary Completion Date :||November 2011|
|Study Completion Date :||December 2011|
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.
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 ]
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