Healthy Males
Conditions
Brief summary
the pharmacokinetics of sildenafil following single doses of sildenafil CT administered with and without water is similar relative to the conventional oral tablet of sildenafil administered with water.
Interventions
DRUGTreatment A
Viagra® 100 mg tablet, administered with water single dose
Blood samples for the analysis of sildenafil in plasma
DRUGTreatment B
Sildenafil 100 mg CT administered with water single dose
DRUGTreatment C
Sildenafil 100 mg CT administered without water single dose
Sponsors
Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Only healthy male volunteers in the 18-40 age range will be included. * At the selection visit allowed normal range for vital signs will be: Blood pressure (with the subject sitting down) 90-130mm Hg systolic and 60-90 * The volunteers' health condition will be determined from their complete clinical history by doctors at the clinical research site and lab test results by certified clinical laboratories mm Hg diastolic, heart rate 55-100 bpm , respiratory rate 14-20 respirations per minute.
Exclusion criteria
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening. * Treatment with a PDE-5 inhibitor within the 4 days preceding the first dose of study medication * History of hypersensitivity to sildenafil citrate or any components of its formulations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-T and Cmax of sildenafil | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| AUC0-inf of sildenafil | 28 days |
| Tmax and half-life of sildenafil | 28 days |
| Adverse events and vital signs | 28 days |
Countries
Mexico
Outcome results
None listed