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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01247805

Enrollment

Registered

2010-11-24

Start date

2011-01-31

Completion date

2011-02-28

Last updated

2021-02-02

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

Conditions

Pulmonary Arterial Hypertention

Keywords

Bioequivalence, Powder for oral suspention

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.

Interventions

DRUGsildenafil citrate

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

DRUGSildenafil citrate

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1\) 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. 2\. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). 3\. An informed consent document signed and dated by the subject or a legally acceptable representative. 4\. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion criteria

1. 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. 2. History of febrile illness within 5 days prior to the first dose. 3. A positive urine drug screen.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
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
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
Adverse events	From FSFV to LSLV, up to 5 weeks
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

Countries

Belgium

Outcome results

None listed

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