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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seoul Pharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01769638
First received: January 7, 2013
Last updated: January 16, 2013
Last verified: January 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Urological Agents

ClinicalTrials.gov processed this record on October 19, 2014