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

Healthy Clinical Trial

Official title:

A Randomised, Open-Label 3-Way Crossover Study To Investigate The Relative Bioavailability Of The Crushed Revatio 20 Mg Tablet Mixed With Apple Sauce, The Extemporaneously Prepared Suspension (EP), And The Intact Revatio 20 Mg Tablet In Healthy Volunteers Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027117
• Other study ID #: A1481275
• Status: Completed
• Phase: Phase 1
• Start date: September 2009
• Est. completion date: September 2009

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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 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 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.

Related Conditions & MeSH terms

• Crush Injuries
• Healthy

Intervention

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

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

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

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUClast		Within 14 hours post dose
Primary	Cmax		Within 14 hours post dose
Secondary	T1/2		Within 14 hours post dose
Secondary	AUCinf		Within 14 hours post dose
Secondary	Tmax		Within 14 hours post dose