At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 55 years inclusive at Screening
- ✓BMI 18 to 32 kg/m² inclusive at Screening
- ✓Good general health based on medical history, laboratory tests, vital signs, ECG, and physical examination
- ✓Able to provide written informed consent and comply with all protocol requirements
- ✕Positive for hepatitis B, hepatitis C, or HIV at Screening
- ✕Positive for SARS-CoV-2 at Check-in
- ✕History of clinically significant neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease
- ✕Current or recent (within 6 months) GI conditions affecting drug absorption (malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis), frequent heartburn, or GI surgery
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Open-Label, Randomized, Single-Dose, 5-Period Crossover Study to Determine the Bioavailability of Two Vonoprazan Orally Disintegrating Tablet Formulations Administered Without Water or Mixed With Water and Administered Via a Syringe Relative to the Vonoprazan Tablet in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Vonoprazan ODT-1 or ODT-2 without Water, Vonoprazan ODT-1 or ODT-2 with Water, and 1 other intervention for Healthy Volunteers. Completed, enrolled 25 participants across 1 site.
Detailed Summary
The primary objective of this study is to assess the bioavailability (BA) of a single oral dose of two vonoprazan orally disintegrating tablet formulations (ODT-1 or ODT-2) administered without water or mixed with water and administered via a syringe relative to the vonoprazan tablet in healthy participants.
Study Details
Timeline
Interventions
Vonoprazan will be administered orally as an ODT-1 or ODT-2 without water
Vonoprazan will be administered orally as an ODT-1 or ODT-2 with water via a syringe
Vonoprazan will be administered orally as a tablet