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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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • ASP-001

    Drug

    Oral liquid suspension of sildenafil

  • Viagra

    Drug

    Sildenafil film-coated tablet

  • ASP-001

    Device

    Bottle/pump containing ASP-001 suspension

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Arm 1 - ASP-001 and ViagraExperimental treatment 3 interventions
Group B: Arm 2 - Viagra and ASP-001Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Cmax

The PK profile of ASP-001 and Viagra in healthy male subjects. Calculation of maximum plasma concentration (Cmax) over the specified timeframe.

Time frame
Baseline and at 24 different timepoints during the 24 hour post-dose
2

Absorption

To determine if the rate and extent of absorption are similar for 100 mg of ASP-001 administered as 8 pumps of the 25 mg/mL oral liquid suspension of sildenafil compared to 100 mg Viagra (sildenafil) administered in the form of a film-coated tablet.

Time frame
Baseline and at several timepoints during the 24 hour post-dose
3

AUCt

The PK profile of ASP-001 and Viagra in healthy male subjects. Calculation of the area under the plasma concentration versus time curve will be calculated using the linear trapezoidal rule from the zero time point to the last quantifiable concentration (AUCt).

Time frame
Baseline and at 24 different timepoints during the 24 hour post-dose
4

AUCi

The PK of ASP-001 and Viagra in healthy male subjects. The area under the plasma concentration versus time curve from zero to infinity (AUCi) will be calculated by adding the last quantifiable concentration (Ct)/ elimination rate contant (Kel) to AUCt.

Time frame
Baseline and at 24 different timepoints during the 24 hour post-dose

Secondary outcomes

1

Number of participants with oral irritation, dizziness, or headache.

To determine the potential of ASP-001 to cause oral irritation, dizziness, or headache. Descriptive summaries (mean, standard deviation (SD), median, minimum, and maximum) of actual values and changes from baseline will be provided.

Time frame
Baseline and different timepoints during the 24 hour post-dose
2

Number of participants with adverse events

The frequency and type of adverse events reported during the study.

Time frame
Baseline and at several timepoints during the 24 hours post-dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aspargo Labs, Inc

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: