Study to Compare the Effects of Viagra® Vs Hezkue® in Healthy Fasted Male Participants.
ConditionErectile Dysfunction
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-55
SponsorAspargo Labs, Inc
About this trial
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
Eligibility criteria
Qualifiers
The participant must be informed of the nature of the study and voluntarily agree to participate by signing an informed consent form prior to any study-specific procedures.
Participants must be healthy male volunteers aged 18 to 55 years (inclusive) at the time of dosing.
Participants must have a body mass index between 18.0 and 29.9 kg/m² (inclusive) and a body weight of 50 to 100 kg (inclusive).
Participants must be judged by the Investigator or designee to be in good general health, as documented by medical history, physical examination, clinical laboratory tests, vital signs, and 12-lead electrocardiogram (ECG). Any deviations from normal ranges must be assessed and deemed not clinically significant by the Investigator or designee.
Disqualifiers
Unwillingness or inability to follow the procedures specified by the protocol.
Participant received any investigational drug/product within 30 days prior to the first dose.
History of significant renal, hepatic, cardiovascular (including orthostatic hypotension), psychiatric, neoplastic, inflammatory, infectious, diabetes mellitus, or other disease which, in the opinion of the Investigator, represents a safety risk for taking part in the study.
Presence of any clinically significant results from laboratory tests, vital signs assessments, and electrocardiograms, as judged by the Investigator and/or designee.
Trial design
Treatments tested in this trial
- ASP-001
- Viagra
- ASP-001
Treatment groups
56 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov