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

NCT01247805 | Completed Phase 1

• 2 other identifiers: A1481293EudraCT 2010-023521-38
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertention

Keywords

Bioequivalence; Powder for oral suspention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (3)

Treatment A

EXPERIMENTAL

Revatio: 1 x 20 mg IR oral tablet.

Drug: sildenafil citrate

Treatment B

EXPERIMENTAL

2 x 10 mg sildenafil citrate IR oral tablet.

Drug: Sildenafil citrate

Treatment C

EXPERIMENTAL

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

Drug: sildenafil citrate

Interventions

sildenafil citrate DRUG

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

Also known as: Revatio

Treatment A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Sildenafil Citrate

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2010
• First Posted: November 24, 2010
• Study Start: January 1, 2011
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: February 2, 2021

Record last verified: 2021-01

Locations

BE (1)