A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT01247805

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

41.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The hypothesis for the trial is that the Sildenafil Citrate Powder for Oral Suspension (10 Mg/ml) bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers and the Sildenafil Citrate 10 Mg immediate release (IR) tablet is bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertention	Drug: sildenafil citrate Drug: Sildenafil citrate Drug: sildenafil citrate	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Pivotal Randomised, Open-Label 3-Way Crossover Study To Demonstrate Bioequivalence Of The Sildenafil Citrate Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil Citrate 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A Revatio: 1 x 20 mg IR oral tablet.	Drug: sildenafil citrate Single oral dose of 1 x 20 mg IR oral tablet. Other Names: Revatio
Experimental: Treatment B 2 x 10 mg sildenafil citrate IR oral tablet.	Drug: Sildenafil citrate single oral dose of 2 x 10 mg sildenafil citrate IR oral tablet. Other Names: Revatio
Experimental: Treatment C 2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose).	Drug: sildenafil citrate single oral dose of 2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose). Other Names: Revatio

Arm

Intervention/Treatment

Experimental: Treatment A

Revatio: 1 x 20 mg IR oral tablet.

Drug: sildenafil citrate

Single oral dose of 1 x 20 mg IR oral tablet.

Other Names:

Revatio

Experimental: Treatment B

2 x 10 mg sildenafil citrate IR oral tablet.

Drug: Sildenafil citrate

single oral dose of 2 x 10 mg sildenafil citrate IR oral tablet.

Other Names:

Revatio

Experimental: Treatment C

2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose).

Drug: sildenafil citrate

single oral dose of 2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose).

Other Names:

Revatio

Outcome Measures

Primary Outcome Measures

Area under the curve (AUC0-T) of sildenafil plasma concentrations from time zero to the time T of last measurable concentration. [Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose]
Maximum sildenafil plasma concentration (Cmax) [Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose]

Secondary Outcome Measures

AUCinf, AUC of sildenafil from time zero to time infinity. AUCinf = AUC0-T+AUCextrapolated [Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose]
AUC%extrapolated of sildenafil. [Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose]
Tmax - time at which maximum sildenafil plasma concentration occurs [Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose]
Adverse events [From FSFV to LSLV, up to 5 weeks]
terminal half-life of sildenafil. [Pre-dose, 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 14 hours post dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy male/female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.

Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
An informed consent document signed and dated by the subject or a legally acceptable representative.
Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, ocular or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) disease or clinical findings at Screening.
History of febrile illness within 5 days prior to the first dose.
A positive urine drug screen.