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HealthyPhase 1NCT04391868

A Bioequivalence Study of Sildenafil Citrate Orally-Disintegrating Film Dosage Form

A Phase 1 study testing Viagra Tablet and Sildenafil Citrate ODF in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to assess the bioequivalence of Sildenafil ODF 50 mg to Viagra® tablet 50 mg under fasted conditions. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Viagra Tablet and Sildenafil Citrate ODF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
30 Jan 2021to 28 Apr 2021
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 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy, gastric bypass).
  • History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb or HCVAb. Hepatitis B vaccination is allowed.
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
  • Participants who are currently prescribed and/or taking nitrates or nitric oxide donors in any form on either a regular or intermittent basis.
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  • Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
  • A positive urine drug test.
  • Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
  • Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTc interval >450 msec, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
  • Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
  • AST or ALT level ≥1.5 × ULN;
  • Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is≤ ULN.
  • History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  • History of sensitivity to heparin or heparin induced thrombocytopenia.
  • Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
  • Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

About this study

Official title: 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

The purpose of this study is to assess the bioequivalence of Sildenafil ODF 50 mg to Viagra® tablet 50 mg under fasted conditions.

Conditions
Healthy
Being tested
Viagra Tablet, Sildenafil Citrate ODF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Viagra TabletDrug

    50 mg tablet on Day 1 of each period

  • Sildenafil Citrate ODFDrug

    50 mg ODF on Day 1 of each period

  • Sildenafil Citrate ODFDrug

    50 mg ODF on Day 1 of each period

Study groups in NCT04391868
Study groupRoleWhat they receive
Viagra tabletActive comparatorSubjects receive a single dose of 50 mg Viagra tablet followed by plasma sampling for 14 hours.
Receives: Drug: Viagra Tablet
Sildenafil citrate ODF without waterExperimentalSubjects receive a single dose of 50 mg sildenafil ODF without water followed by plasma sampling for 14 hours.
Receives: Drug: Sildenafil Citrate ODF
Sildenafil citrate ODF with waterExperimentalSubjects receive a single dose of 50 mg sildenafil ODF with water followed by plasma sampling for 14 hours.
Receives: Drug: Sildenafil Citrate ODF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

    AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

    Measured: 0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hours post-dose

  2. Maximum Observed Plasma Concentration (Cmax)

    Maximum Observed Plasma Concentration (Cmax)

    Measured: 0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hours post-dose

Secondary outcomes (4)

  1. Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment

    Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

    Measured: Baseline up to 2 days after last dose of study medication

  2. Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities

    Laboratory parameters included: hematology, chemistry and urine. Clinical significance of laboratory parameters was determined at the investigator's discretion.

    Measured: Baseline up to 2 days after last dose of study medication

  3. Number of Participants With Clinically Significant Change From Baseline in Vital Signs

    Vital signs are obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion.

    Measured: Baseline up to 2 days after last dose of study medication

  4. Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings

    Physical examination included examination of the head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.

    Measured: Baseline up to 2 days after last dose of study medication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2020
  2. Study start30 Jan 2021 (estimated)
  3. Primary completion28 Apr 2021 (estimated)
  4. Study completion28 Apr 2021 (estimated)

Why it stopped: The project has been transferred to Viatris

Resources

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
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04391868
Sponsor's protocol ID
A1481340
Status last verified
Feb 2021
First submitted
4 May 2020
Last updated
15 Feb 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Viagra Tablet and Sildenafil Citrate ODF in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

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 4 inclusion and 18 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: withdrawn, as of the sponsor's last update on 15 Feb 2021. 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] (time frame: 0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hours post-dose). 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?

On the ClinicalTrials.gov record for NCT04391868.

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 15 Feb 2021.

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