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New dissolving tablets for stomach acid drug pass early absorption test
NCT ID NCT06831344
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-stage study tested two new quick-melt versions of the stomach acid drug vonoprazan in 25 healthy adults. The goal was to see how well the body absorbs these new forms, taken with or without water, compared to the standard tablet. The results help determine if these easier-to-take versions work similarly to the original pill.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vonoprazan
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
25 people
The number who actually took part.
- Started
-
Feb 2025
- Finished
-
Apr 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * The participant is 18 to 55 years of age, inclusive, at Screening. * The participant has a body mass index (BMI) 18 to 32 kg/m2, inclusive, at Screening. * The participant is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at Screening. * Female participants of reproductive potential must use an acceptable method of birth control (ie, diaphragm with spermicide, intrauterine device, condom with foam or vaginal spermicide, oral contraceptives, or abstinence) from signing the informed consent form (ICF) until 4 weeks after the last dose of study drug or be surgically sterile (ie, hysterectomy or bilateral oophorectomy) or postmenopausal (defined as amenorrhea for 12 consecutive months and documented plasma follicle stimulating hormone \[FSH\] level \>40 IU/mL during Screening). * Female participants must have a negative pregnancy test at Screening and upon Check-in. * The participant agrees to comply with all protocol requirements. * The participant is able to provide written informed consent. Exclusion Criteria: * The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at Screening. * The participant has a positive test result for the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Check-in. * The participant has a history of a clinically significant neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality that may impact the ability of the subject to participate. * The participant has current or recent (within 6 months) gastrointestinal conditions that would be expected to influence the absorption of drugs (eg, history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis (EE)), frequent (more than once per week) occurrence of heartburn, or any surgical intervention. * The participant has any other clinically significant findings on physical examination, clinical laboratory abnormalities, and/or ECG results that preclude his/her participation in the study, as deemed by the investigator. * The participant has used any prescription (excluding hormonal birth control) and/or over-the-counter medications (including Cytochrome P450 3A4 (CYP3A4) inducers) except acetaminophen (up to 2 g per day), including herbal or nutritional supplements, within 14 days before the first dose of study drug, and/or is expected to require any such medication during the course of the study until the end of confinement on Study Day 23. * The participant has consumed grapefruit and/or grapefruit juice, Seville orange or Seville orange-containing products (eg, marmalade), or other food products that may be CYP3A4 inhibitors (eg, vegetables from the mustard green family \[kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard\] and charbroiled meats) within 7 days before the first dose of study drug and/or is expected to be unable to abstain through the study. * The participant has consumed caffeine- or xanthine-containing products within 48 hours (or 5 half-lives) before the first dose of study drug and/or is unable to abstain through the study. * The participant is a smoker and/or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6 months before the first dose of study drug. * The participant has a history of alcohol abuse and/or drug addiction within the last year or excessive alcohol consumption (regular alcohol intake \>21 units per week for male subjects and \>14 units of alcohol per week for female subjects; 1 unit is equal to approximately ½ pint \[200 mL\] of beer, 1 small glass \[100 mL\] of wine, or 1 measure \[25 mL\] of spirits) or use of alcohol 48 hours before the first dose of study drug. * The participant has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at Screening or Check-in. * The participant is involved in strenuous activity or contact sports within 24 hours before the first dose of study drug and during the study. * The participant has donated blood or blood products \>450 mL within 30 days before the first dose of study drug. * The participant has a history of relevant drug and/or food allergies (ie, allergy to vonoprazan or excipients or any significant food allergy that could preclude a standard diet in the clinical unit). * The participant has received a study drug in another investigational study within 5-times the t1/2 of the study drug or 30 days of dosing, whichever is longer. * Female participants who are pregnant or lactating; intend to become pregnant before, during, or within 4 weeks after participating in this study; or intend to donate ova during this time period. * The participant is not suitable for entry into the study in the opinion of the investigator.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
7551 Metro Center Dr Ste 200
Austin, Texas, 78744, United States
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