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Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 1

Locations

Singapore

Study Type

Interventional

Intervention

Sildenafil

About this trial

This is an interventional basic science trial for Erectile Dysfunction focused on measuring Bioavailability Food Effect Oral Dissolving Tablet (ODT)

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sildenafil ODT tablet 50 mg, Fasted

Sildenafil ODT tablet 50 mg, Fed

Arm Description

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

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

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax)

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).

Secondary Outcome Measures

Time to Reach Maximum Observed Plasma Concentration (Tmax)

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

AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).

Plasma Decay Half Life (t1/2)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Full Information

NCT ID

NCT01254396

First Posted

November 19, 2010

Last Updated

January 28, 2021

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01254396

Brief Title

Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.

Official Title

An Open Label Crossover Study In Healthy Older Male Subjects To Evaluate The Pharmacokinetics And Safety Of An Orally Disintegrating Tablet Formulation Of Sildenafil Administered Without Water Under Fed Compared To Fasted Conditions

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

Keywords

Bioavailability Food Effect Oral Dissolving Tablet (ODT)

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sildenafil ODT tablet 50 mg, Fasted

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sildenafil ODT tablet 50 mg, Fed

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sildenafil

Intervention Description

Orally Disintegrating Tablet, 50 mg, Single Dose

Intervention Type

Drug

Intervention Name(s)

Sildenafil

Intervention Description

Orally Disintegrating Tablet, 50 mg, Single Dose

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration (Cmax)

Time Frame

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

Title

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

Description

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

Time Frame

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 Outcome Measure Information:

Title

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time Frame

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

Title

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

Description

AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).

Time Frame

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

Title

Plasma Decay Half Life (t1/2)

Description

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time Frame

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Evidence or history of clinically significant abnormalities Have baseline orthostatic hypotension Positive drug screen, excessive alcohol and tobacco use

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Singapore

ZIP/Postal Code

188770

Country

Singapore

12. IPD Sharing Statement

Citations:

PubMed Identifier

24447534

Citation

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.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481290&StudyName=Pharmacokinetics%20Of%20Sildenafil%20Orally%20Disintegrating%20Tablet%20Formulation%0AGiven%20With%20Or%20Without%20Food.%20%20%0A

Description

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Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.

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