Safety and Pharmacokinetic Comparison of Sildenafil ODF and FCT Formulations in Healthy Korean Volunteers - Full Text View

Purpose

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	Intervention	Phase
Healthy	Drug: SPO1101 Drug: SPO1101D	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Sildenafil Sildenafil citrate

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Enrollment:	115
Study Start Date:	September 2011
Study Completion Date:	December 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: SPO1101	Drug: SPO1101 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.
Experimental: SPO1101D	Drug: SPO1101D 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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Eligible subjects were healthy male volunteers between the ages of 20 and 50 years and within 20% of their ideal body weight, and
With no congenital abnormality or chronic disease.

Exclusion Criteria:

Key exclusion criteria included:

history of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic, or hemorrhagic disease;
anatomical abnormality of penis or factors that cause priapism (e.g., sicklemia, multiple myeloma, leukemia);
clinically significant findings on routine laboratory (serology, hematology, serum chemistry, and urinalysis), ECG or color blindness tests [8, 16];
history of hypersensitivity reaction to PDE5 inhibitor including sildenafil;
use of prescription drugs within 14 days before the study that had the potential to interact with the study medication; and
use of any substance that could induce or inhibit cytochrome P450 3A4 synthesis (eg, St. John's wort, other herbal medications).

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Seoul Pharma Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01769638 History of Changes
Other Study ID Numbers:	4-2011-0462
Study First Received:	January 7, 2013
Last Updated:	January 16, 2013
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul Pharma Co., Ltd.:

Orally disintegrating Film
Film Coated Tablet
Sildenafil
Pharmacokinetics

Additional relevant MeSH terms:

Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013