Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT06782659
Brief Summary:
The objective of this phase 1, open-label, single-center, two-way crossover trial is to evaluate the pharmacokinetics (PK), safety, and tolerability of 100 mg ASP-001 oral liquid suspension versus 100 mg Viagra (sildenafil citrate) tablets in fasted, healthy male volunteers
Detailed Description:
This is a Phase 1, open-label, single-center, two-way crossover study to evaluate the pharmacokinetics (PK), bioequivalence (BE), safety, and tolerability of ASP-001 (oral liquid suspension of sildenafil) compared to Viagra (sildenafil film-coated tablet) under fasted conditions in 56 healthy adult male participants.
The study aims to demonstrate bioequivalence between the ASP-001 and Viagra formulations and to evaluate whether the absorption rate of ASP-001 is superior to that of Viagra. Additionally, the study assesses the tolerability of ASP-001, including potential for oral irritation, dizziness, or headache.
Participants are randomized to one of these two sequences:
* Sequence 1: ASP-001 in Period I, Viagra in Period II.
* Sequence 2: Viagra in Period I, ASP-001 in Period II
There is a washout period of 6 days between treatment periods.
Enrollment may be increased at any point in this trial to ensure a minimum of 56 evaluable participants.
Study:
NCT06782659
Study Brief:
Protocol Section:
NCT06782659