A Relative Bioavailability Study of Revatio for the Crushed Tablets, Extemporaneously Prepared Formulation, and the Intact Tablets at 20 mg Dose in Healthy Volunteers

NCT01027117 | Completed Phase 1

• 1 other identifier: A1481275
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized, open-label, 3-treatment, 3-period, crossover, single-dose study in healthy subjects. Eighteen (18) subjects will complete the study; dropouts may be replaced at the discretion of the sponsor. Three treatments are: Treatment A: Revatio 20 mg intact tablet. Treatment B: Revatio 20 mg crushed tablet mixed with apple sauce. Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP). Blood samples for the analysis of sildenafil in plasma will be obtained pre-dose and up to 14 hours post dose in each period. Tolerability and safety will be assessed by reported adverse events during each study period.

Conditions

Healthy

Keywords

Bioavailability; Revatio; Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• AUClast

  Within 14 hours post dose

• Cmax

  Within 14 hours post dose

Secondary Outcomes (3)

• T1/2

  Within 14 hours post dose

• AUCinf

  Within 14 hours post dose

• Tmax

  Within 14 hours post dose

Study Arms (3)

Treatment A

ACTIVE COMPARATOR

Revatio 20 mg intact tablet. This is the reference treatment arm.

Drug: Revatio

Treatment B

EXPERIMENTAL

Treatment B: Revatio 20 mg crushed tablet mixed with apple sauce.

Drug: Revatio

Treatment C

EXPERIMENTAL

Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP).

Drug: Revatio

Interventions

Revatio DRUG

Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.

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 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 time of dosing) disease or clinical findings at Screening.
• History of febrile illness within 5 days prior to the first dose.
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• 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, 1070, Belgium

Location

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: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: December 7, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

BE (1)