Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT01737203

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Healthy	Drug: Viagra Drug: sildenafil ODT Drug: sildenafil ODT	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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

Arm

Intervention/Treatment

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 Names:

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

Outcome Measures

Primary Outcome Measures

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose]
Maximum Observed Plasma Concentration (Cmax) [0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose]

Secondary Outcome Measures

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose]
Time to Reach Maximum Observed Plasma Concentration (Tmax) [0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose]
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose]
Maximum Observed Plasma Concentration (Cmax) [0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose]
Plasma Decay Half-Life (t1/2) [0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose]
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [9 days]
Diastolic and Systolic Blood Pressure [9 days]
12-lead electrocardiogram (ECG) [9 days]
Pulse rate (PR) [9 days]
Number of Participants With Laboratory Test Values of Potential Clinical Importance [9 days]
Mean Residence Time(MRT) [0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Minato-ku	Tokyo	Japan

Sponsors and Collaborators

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

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT01737203

Other Study ID Numbers:

A1481315

First Posted:

Nov 29, 2012

Last Update Posted:

Jan 28, 2021

Last Verified:

Jan 1, 2021

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

Viagra

ODT

bioquivalence

Additional relevant MeSH terms:

Sildenafil Citrate

Study Results

No Results Posted as of Jan 28, 2021