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Safety and Pharmacokinetic Comparison of Sildenafil ODF and FCT Formulations in Healthy Korean Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01769638
First Posted: January 17, 2013
Last Update Posted: January 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Seoul Pharma Co., Ltd.
  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
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seoul Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01769638     History of Changes
Other Study ID Numbers: 4-2011-0462
First Submitted: January 7, 2013
First Posted: January 17, 2013
Last Update Posted: January 17, 2013
Last Verified: January 2013

Keywords provided by Seoul Pharma Co., Ltd.:
Orally disintegrating Film
Film Coated Tablet
Sildenafil
Pharmacokinetics

Additional relevant MeSH terms:
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents