Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01737203
First received: August 31, 2012
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under fasted conditions.


Condition Intervention Phase
Healthy
Drug: Viagra
Drug: sildenafil ODT
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Phase 1, Open-Label, Randomized, Single-Dose, 3-Way Crossover Study Assessing Bioequivalence Of Sildenafil 50 Mg Orally-Disintegrating Tablet With Or Without Water To Viagra® 50 Mg Oral Tablet With Water Under Fasted Condition

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [ Time Frame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose ] [ Designated as safety issue: No ]
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 9 days ] [ Designated as safety issue: No ]
  • Diastolic and Systolic Blood Pressure [ Time Frame: 9 days ] [ Designated as safety issue: No ]
  • 12-lead electrocardiogram (ECG) [ Time Frame: 9 days ] [ Designated as safety issue: No ]
  • Pulse rate (PR) [ Time Frame: 9 days ] [ Designated as safety issue: No ]
  • Number of Participants With Laboratory Test Values of Potential Clinical Importance [ Time Frame: 9 days ] [ Designated as safety issue: No ]
  • Mean Residence Time(MRT) [ Time Frame: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: August 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Viagra
Oral tablet of sildenafil citrate (Japanese commercial tablet: Viagra® tablet) 50 mg as a single oral dose under fasted conditions
Drug: Viagra
50 mg tablet on Day 1 of each period
Other Name: sildenafil citrate
Experimental: ODT without water
Sildenafil ODT 50 mg without water as a single oral dose under fasted conditions
Drug: sildenafil ODT
50 mg tablet on Day 1 of each period
Experimental: ODT with water
Sildenafil ODT 50 mg with water as a single oral dose under fasted conditions
Drug: sildenafil ODT
50 mg tablet on Day 1 of each period

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Japanese male subjects between the ages of 20 and 55 years.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Baseline orthostatic hypotension defined as a >=20 mm Hg reduction in systolic blood pressure (SBP), a >=10 mm Hg reduction in diastolic blood pressure (DBP) or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position.
  • Subjects who are currently prescribed or taking nitrates or nitric oxide donors in any form on either a regular or intermittent basis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737203

Locations
Japan
Pfizer Investigational Site
Minato-ku, Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01737203     History of Changes
Other Study ID Numbers: A1481315
Study First Received: August 31, 2012
Last Updated: November 26, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
Viagra
ODT
bioquivalence

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 April 16, 2014