Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: sildenafil ODT; Drug: Viagra

• Registration Number: NCT01737203
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-31
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-29
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 53

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ODT without water	sildenafil ODT	Sildenafil ODT 50 mg without water as a single oral dose under fasted conditions
ODT with water	sildenafil ODT	Sildenafil ODT 50 mg with water as a single oral dose under fasted conditions
Viagra	Viagra	Oral tablet of sildenafil citrate (Japanese commercial tablet: Viagra® tablet) 50 mg as a single oral dose under fasted conditions

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	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
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
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
Diastolic and Systolic Blood Pressure	9 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Minato-ku, Tokyo, Japan