Trial Profile

PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, 3-WAY, 6-SEQUENCE CROSSOVER STUDY TO DEMONSTRATE BIOEQUIVALENCE OF SILDENAFIL ORALLY-DISINTEGRATING FILM 50 MG WITH OR WITHOUT WATER TO ORAL TABLET OF SILDENAFIL CITRATE (VIAGRA(Registered)) 50 MG UNDER FASTED CONDITION IN HEALTHY MALE PARTICIPANTS

Status: Withdrawn prior to enrolment

Phase of Trial: Phase I

Latest Information Update: 16 Feb 2021

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At a glance

Drugs Sildenafil (Primary) ; Sildenafil
Indications Diastolic heart failure; Erectile dysfunction; Heart failure; Pulmonary arterial hypertension; Pulmonary hypertension
Focus Pharmacokinetics
Sponsors Viatris

10 Feb 2021 Planned End Date changed from 15 Sep 2020 to 28 Apr 2021.
10 Feb 2021 Planned primary completion date changed from 15 Sep 2020 to 28 Apr 2021.
10 Feb 2021 Planned initiation date changed from 19 Jun 2020 to 30 Jan 2021.

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