Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Viagra · 3 trials · 3 indications
Area under the blood concentration-time profile from time zero to last experimentally determined concentration measured in nanograms\*hour/milliliter (ng\*hr/mL).
Maximum plasma concentration measured in nanograms per milliliter (ng/mL).
| Arm | Type | Description |
|---|---|---|
| Viagra | ACTIVE_COMPARATOR | Oral tablet of sildenafil citrate (Japanese commercial tablet: Viagra® tablet) 50 mg as a single oral dose under fasted conditions |
| ODT without water | EXPERIMENTAL | Sildenafil ODT 50 mg without water as a single oral dose under fasted conditions |
| ODT with water | EXPERIMENTAL | Sildenafil ODT 50 mg with water as a single oral dose under fasted conditions |
| Test 1 | EXPERIMENTAL | - |
| Test 2 | EXPERIMENTAL | - |
| Reference | ACTIVE_COMPARATOR | - |
| Viagra 50 mg tablet, administered with water. | ACTIVE_COMPARATOR | - |
| Formulation B ODT tablet 50 mg, administered without water. | EXPERIMENTAL | - |
| Formulation C ODT tablet 50 mg, administered without water. | EXPERIMENTAL | - |
| Formulation D ODT tablet 50 mg, administered without water. | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Viagra | DRUG | 50 mg tablet on Day 1 of each period |
| sildenafil ODT | DRUG | 50 mg tablet on Day 1 of each period |
| sildenafil citrate 100 mg CT | DRUG | sildenafil citrate 100 mg CT, single dose without water |
| Viagra® | DRUG | sildenafil citrate 100 mg film-coated tablet (Viagra®), single dose |
| Viagra 50 mg tablet | DRUG | Commercial tablet, 50 mg, single dose administered with water |
| Formulation B ODT tablet 50 mg | DRUG | Oral disintegrating tablet (ODT), 50 mg, single dose administered without water |
| Formulation C ODT tablet 50 mg | DRUG | ODT, 50 mg, single dose administered without water |
| Formulation D ODT tablet 50 mg | DRUG | ODT, 50 mg, single dose, administered without water |
Inclusion Criteria: * Healthy Japanese male subjects between the ages of 20 and 55 years. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria: * Baseline orthostatic hypotension defined as a \>=20 mm Hg reduction in systolic blood pressure ...
Viagra is a small molecule drug developed by Pfizer, Inc. (NYSE: PFE) for the treatment of erectile dysfunction. It has also been studied in healthy volunteers to assess bioavailability and bioequivalence of different formulations. The drug is in Phase 1 clinical development, with completed trials in Brazil, the United States, and Japan.
Viagra, also known as sildenafil citrate, is a phosphodiesterase type 5 (PDE5) inhibitor. It works by inhibiting the PDE5 enzyme, which increases blood flow to the penis, helping to achieve and maintain an erection. This mechanism is relevant for its use in erectile dysfunction.
Viagra is developed by Pfizer, Inc., a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical trials, with one completed study and no active trials.
Viagra is in Phase 1 clinical development. It has completed one Phase 1 trial with a total enrollment of 53 participants. The drug is not yet approved by the FDA, and it remains investigational for the studied indications.
Viagra has been studied in three completed Phase 1 trials: NCT00904748, a relative bioavailability study in Brazil with 47 participants; NCT00950404, a bioavailability study in the United States with 16 participants; and NCT01737203, a bioequivalence study in Japan with 53 participants. All trials were completed.
Yes, Viagra is the brand name for sildenafil citrate. The clinical trials for Viagra assess formulations of sildenafil citrate, including oral disintegrating tablets and standard oral tablets, to compare their bioavailability and bioequivalence.