Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737203
• Other study ID #: A1481315
• Status: Completed
• Phase: Phase 1
• Start date: August 2012
• Est. completion date: September 2012

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Viagra
50 mg tablet on Day 1 of each period
• sildenafil ODT
50 mg tablet on Day 1 of each period
• sildenafil ODT
50 mg tablet on Day 1 of each period

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Minato-ku	Tokyo

Sponsors (1)

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

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]		0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Primary	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	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
Secondary	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
Secondary	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
Secondary	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	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
Secondary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		9 days
Secondary	Diastolic and Systolic Blood Pressure		9 days
Secondary	12-lead electrocardiogram (ECG)		9 days
Secondary	Pulse rate (PR)		9 days
Secondary	Number of Participants With Laboratory Test Values of Potential Clinical Importance		9 days
Secondary	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

External Links

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