Erectile DysfunctionPhase 1NCT04762082
A Single Dose Randomized Five-Way Crossover Pharmacokinetics (PK) Study of Tadalafil Semi-Chewable (Gummy) Formulations in Healthy Volunteers
A Phase 1 study testing Tadalafil 10 MG in people with Erectile Dysfunction, run by Seattle Gummy Company.
Trial summary
This is a randomized, open-label, single-dose, five-period crossover, relative bioavailability study to evaluate tadalafil gummy 10mg and tadalafil oral tablets 10mg in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Tadalafil 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 30 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male 19-65 years of age;
- Available to participate for the planned duration of the study;
- Able and willing to complete the informed consent process;
- Agree to have blood samples collected and stored for the study;
- Agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the course of the study;
- Have not taken finasteride or dutasteride therapy, any other lower urinary tract symptom (LUTS) therapy or phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to the study;
- Have not taken nitrates, alpha blockers, antihypertensives, alcohol, CYP3A4 inhibitors and CYP3A4 inducers for a specified duration of time prior to the study;
- Have a prostate specific antigen (PSA) score within acceptable range defined for study or negative biopsy of the prostate for cancer within 12 months of the study.
Who cannot join
- A condition in which repeated blood draws poses more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access;
- A condition that requires active medical intervention or monitoring to avert serious danger to the subject's health or well-being;
- subjects with dentures, partial dentures or braces, subjects with swallowing disorders and subjects who abuse drugs, alcohol or tobacco;
- Currently taking nitrates or nitro compounds, alpha blockers, antihypertensives, alcohol, CYP3A4 inhibitors, CYP3A4 inducers;
- Currently taking any medicines known to conflict with tadalafil;
- History of urinary retention or lower urinary tract (bladder) stones 6 months before the start of the study;
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- History of bladder outlet obstruction or urethral obstruction due to stricture, valves, sclerosis, or tumor;
- History of diabetes;
- History of cardiac conditions including angina requiring certain treatment with nitrates, heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study;
- Certain neurological conditions associated with bladder problems or injuries to the brain or spinal cord within a specified time before starting the study.
Trial locations and contacts
No sites are listed yet.
About this study
This is a randomized, open-label, single-dose, five-period crossover, relative bioavailability study to evaluate tadalafil gummy 10mg and tadalafil oral tablets 10mg in healthy volunteers
Read the detailed description
This is an open-label, single dose, randomized, five-period, crossover design study to evaluate the relative bioavailability of a single oral dose of tadalafil gummy 10 mg (Test) and tadalafil oral tablets 10 mg (Reference) under fasted conditions in healthy adult male and female subjects, and the impact on the bioavailability of tadalafil gummy sugar free 10 mg when administered with food, when administered with or without water, and when chewed or swallowed whole.
Each subject will receive tadalafil gummy (10 mg) or tadalafil tablet and thereby will be his/hers own control.
- Conditions
- Erectile Dysfunction
- Being tested
- Tadalafil 10 MG
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 10 MGDrug
comparison of tadalafil gummy 10mg and tadalafil oral tablet 10mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Test | Experimental | Single oral dose of tadalafil gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fasted conditions Receives: Drug: Tadalafil 10 MG |
| Treatment B: Reference | Active comparator | Single oral dose of tadalafil oral tablets 10 mg, administered with approximately 240 mL of room temperature water, under fasted conditions Receives: Drug: Tadalafil 10 MG |
| Treatment C: Test | Experimental | Single oral dose of tadalafil gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fed conditions Receives: Drug: Tadalafil 10 MG |
| Treatment D: Test | Experimental | Single oral dose of tadalafil gummy 10 mg, chewed, administered with no water, under fasted conditions Receives: Drug: Tadalafil 10 MG |
| Treatment E: Test | Experimental | Single oral dose of tadalafil gummy 10 mg, swallowed whole, administered with approximately 240 mL of room temperature water, under fasted conditions Receives: Drug: Tadalafil 10 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum plasma cetirizine concentration (Cmax)
PK blood samples to measure plasma concentrations of tadalafil will be collected by direct venipuncture or by use of an indwelling cannula. Blood will be collected into tubes containing K2EDTA for determination of plasma tadalafil concentration at time 0 (within 60 minutes pre-dose), 10, 20 minute post-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post-dose. Plasma tadalafil concentrations will be listed at each time point by subject and summarized by treatment at each time point using descriptive statistics (n, mean, standard deviation (SD), Coefficient of variation (CV%), median, minimum and maximum values). Pharmacokinetic calculations will be performed based on actual time of blood sample collection, using non-compartmental methods with Phoenix WinNonlin Version 8.1 (Certara USA, Inc., Princeton, New Jersey, USA). Plots of mean concentrations of plasma tadalafil versus time will be generated and Cmax will be generated from the plot.
Measured: 96 hours
area under the plasma drug concentration versus time curve (AUC)
AUC will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ). AUC will be calculated to the last measurable observation (AUC0-t) and extrapolated to infinity (AUC0 ∞).
Measured: 96 hours
Secondary outcomes (3)
time to Cmax (Tmax)
Tmax will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ).
Measured: 96 hours
elimination half-life (t½)
t½ will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ).
Measured: 96 hours
terminal elimination rate constant (Kel).
Kel will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ).
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 May 2025 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Eligible subjects will receive a single oral dose of one of five treatments (Treatments A, B, C, D or E) in five separate periods in a randomly assigned sequence, with each treatment separated by an approximate 5-day washout period. In each study period, dosing will occur in the morning after an overnight fast of at least 10 hours. All doses will be administered under fasted conditions except for Treatment C, when tadalafil gummy 10 mg will be administered after consumption of a high-calorie, high-fat breakfast. All doses will be administered with approximately 240 mL of room temperature water except for Treatment D, when tadalafil gummy 10 mg dose will be administered without water. All doses of tadalafil gummy 10 mg will be chewed before swallowing except for Treatment E, when subjects will be instructed to swallow the dose whole.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Gummy Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762082
- Sponsor's protocol ID
- P-002-2020
- Status last verified
- Jun 2024
- First submitted
- 17 Feb 2021
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Randomized Five-Way Crossover Pharmacokinetics (PK) Study of Tadalafil Semi-Chewable (Gummy) Formulations in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04762082
- Acronym / sponsor ID
- P-002-2020
- Conditions
- Erectile Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seattle Gummy CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label, single-dose, five-period crossover, relative bioavailability study to evaluate tadalafil gummy 10mg and tadalafil oral tablets 10mg in healthy volunteers
Detailed description
This is an open-label, single dose, randomized, five-period, crossover design study to evaluate the relative bioavailability of a single oral dose of tadalafil gummy 10 mg (Test) and tadalafil oral tablets 10 mg (Reference) under fasted conditions in healthy adult male and female subjects, and the impact on the bioavailability of tadalafil gummy sugar free 10 mg when administered with food, when administered with or without water, and when chewed or swallowed whole.
Each subject will receive tadalafil gummy (10 mg) or tadalafil tablet and thereby will be his/hers own control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Eligible subjects will receive a single oral dose of one of five treatments (Treatments A, B, C, D or E) in five separate periods in a randomly assigned sequence, with each treatment separated by an approximate 5-day washout period. In each study period, dosing will occur in the morning after an overnight fast of at least 10 hours. All doses will be administered under fasted conditions except for Treatment C, when tadalafil gummy 10 mg will be administered after consumption of a high-calorie, high-fat breakfast. All doses will be administered with approximately 240 mL of room temperature water except for Treatment D, when tadalafil gummy 10 mg dose will be administered without water. All doses of tadalafil gummy 10 mg will be chewed before swallowing except for Treatment E, when subjects will be instructed to swallow the dose whole.
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Test | Experimental | Drug: Tadalafil 10 MGSingle oral dose of tadalafil gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fasted conditions |
| Treatment B: Reference | Active comparator | Drug: Tadalafil 10 MGSingle oral dose of tadalafil oral tablets 10 mg, administered with approximately 240 mL of room temperature water, under fasted conditions |
| Treatment C: Test | Experimental | Drug: Tadalafil 10 MGSingle oral dose of tadalafil gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fed conditions |
| Treatment D: Test | Experimental | Drug: Tadalafil 10 MGSingle oral dose of tadalafil gummy 10 mg, chewed, administered with no water, under fasted conditions |
| Treatment E: Test | Experimental | Drug: Tadalafil 10 MGSingle oral dose of tadalafil gummy 10 mg, swallowed whole, administered with approximately 240 mL of room temperature water, under fasted conditions |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- male 19-65 years of age;
- Available to participate for the planned duration of the study;
- Able and willing to complete the informed consent process;
- Agree to have blood samples collected and stored for the study;
- Agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the course of the study;
Key exclusion criteria (10 listed)
- A condition in which repeated blood draws poses more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access;
- A condition that requires active medical intervention or monitoring to avert serious danger to the subject's health or well-being;
- subjects with dentures, partial dentures or braces, subjects with swallowing disorders and subjects who abuse drugs, alcohol or tobacco;
- Currently taking nitrates or nitro compounds, alpha blockers, antihypertensives, alcohol, CYP3A4 inhibitors, CYP3A4 inducers;
- Currently taking any medicines known to conflict with tadalafil;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tadalafil 10 MGcomparison of tadalafil gummy 10mg and tadalafil oral tablet 10mg | Drug | Treatment A: Test, Treatment B: Reference, Treatment C: Test, Treatment D: Test, Treatment E: Test |
Primary outcome
maximum plasma cetirizine concentration (Cmax)
Time frame: 96 hours
PK blood samples to measure plasma concentrations of tadalafil will be collected by direct venipuncture or by use of an indwelling cannula. Blood will be collected into tubes containing K2EDTA for determination of plasma tadalafil concentration at time 0 (within 60 minutes pre-dose), 10, 20 minute post-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post-dose. Plasma tadalafil concentrations will be listed at each time point by subject and summarized by treatment at each time point using descriptive statistics (n, mean, standard deviation (SD), Coefficient of variation (CV%), median, minimum and maximum values). Pharmacokinetic calculations will be performed based on actual time of blood sample collection, using non-compartmental methods with Phoenix WinNonlin Version 8.1 (Certara USA, Inc., Princeton, New Jersey, USA). Plots of mean concentrations of plasma tadalafil versus time will be generated and Cmax will be generated from the plot.
area under the plasma drug concentration versus time curve (AUC)
Time frame: 96 hours
AUC will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ). AUC will be calculated to the last measurable observation (AUC0-t) and extrapolated to infinity (AUC0 ∞).
3 secondary outcomes
time to Cmax (Tmax)
Time frame: 96 hours
elimination half-life (t½)
Time frame: 96 hours
terminal elimination rate constant (Kel).
Time frame: 96 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tadalafil 10 MG in people with Erectile Dysfunction, run by Seattle Gummy Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact President (2062570464, clinicaltrial@seattlegummy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum plasma cetirizine concentration (Cmax) (time frame: 96 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.