Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01737203

Enrollment

Registered

2012-11-29

Start date

2012-08-31

Completion date

2012-09-30

Last updated

2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Viagra, ODT, bioquivalence

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.

Interventions

DRUGViagra

50 mg tablet on Day 1 of each period

DRUGsildenafil ODT

50 mg tablet on Day 1 of each period

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
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
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
Diastolic and Systolic Blood Pressure	9 days
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026