NCT01254396

Brief Summary

This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2010

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2010

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 8, 2012

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

1 month

First QC Date

November 19, 2010

Results QC Date

January 7, 2012

Last Update Submit

January 28, 2021

Conditions

Erectile Dysfunction

Keywords

Bioavailability Food Effect Oral Dissolving Tablet (ODT)

Outcome Measures

Primary Outcomes (2)

  • Maximum Observed Plasma Concentration (Cmax)

    0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).

    0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours (hrs) post-dose

Secondary Outcomes (3)

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose

  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]

    0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose

  • Plasma Decay Half Life (t1/2)

    0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose

Study Arms (2)

Sildenafil ODT tablet 50 mg, Fasted

ACTIVE COMPARATOR

Treatment A: Sildenafil ODT tablet 50 mg, administered without water under fasted conditions.

Drug: Sildenafil

Sildenafil ODT tablet 50 mg, Fed

EXPERIMENTAL

Treatment B: Sildenafil ODT tablet 50 mg, administered without water under fed conditions.

Drug: Sildenafil

Interventions

SildenafilDRUG

Orally Disintegrating Tablet, 50 mg, Single Dose

Sildenafil ODT tablet 50 mg, Fasted

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Otherwise healthy male subjects age 45 years or older with or without erectile dysfunction.
  • Body Mass Index (BMI) of 17.5 to 32.5 kg/m2.
  • Signed Informed Consent.

You may not qualify if:

  • Evidence or history of clinically significant abnormalities
  • Have baseline orthostatic hypotension
  • Positive drug screen, excessive alcohol and tobacco use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Publications (1)

  • Damle B, Duczynski G, Jeffers BW, Crownover P, Coupe A, LaBadie RR. Pharmacokinetics of a novel orodispersible tablet of sildenafil in healthy subjects. Clin Ther. 2014 Feb 1;36(2):236-44. doi: 10.1016/j.clinthera.2013.12.010. Epub 2014 Jan 18.

    PMID: 24447534DERIVED

Related Links

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

AUC (0-t) was the intended primary outcome measure.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2010

First Posted

December 6, 2010

Study Start

December 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 1, 2021

Results First Posted

February 8, 2012

Record last verified: 2021-01

Locations

SG(1)