Bioequivalence Study to Compare Vonoprazan 20 mg Film Coated Tablets Versus Voquezna® 20 mg (Vono… (NCT07278349) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study to Compare Vonoprazan 20 mg Film Coated Tablets Versus Voquezna® 20 mg (Vonoprazan) Tablets
Jordan28 participantsStarted 2025-09-21
Plain-language summary
Randomized, Single Dose, Two-Way Crossover, Open Label bioequivalence study to compare Vonoprazan 20 mg Film Coated Tablets versus Voquezna® 20 mg (Vonoprazan) Tablets an oral administration to healthy adults under fasting conditions
Who can participate
Age range18 Years – 50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy participant, age 18 to 50 years, inclusive.
* Body Mass Index (BMI) range5 is within 18.5 - 30 Kg/m2.
* Participant does not have a known allergy to the drug under investigation or any of its ingredients or any other related drugs.
* Standard ECG assessment is normal and no QTc Prolongation (QTc ≤ 450 ms in male and QTc ≤ 460 ms in females).
* Medical history and physical examination within medically acceptable criteria.
* Participant is capable of consent.
Exclusion Criteria:
* Demographics data with significant deviations from the normal ranges.
* Presence of any clinically significant results from laboratory reference ranges, however, ALP and creatinine will be accepted if below reference range after being evaluated by the physician as clinically not significant. RBC count, PCV, MCV, MCH and MCHC with deviation of more than 5% of the reference limits for all laboratory tests that are performed not longer than two weeks before the initiation of the clinical study.
* History of drug or alcohol abuse.
* Participant is a heavy smoker (more than 10 cigarettes per day).
* Participant does not agree to not taking any prescription or non-prescription drugs within at least two weeks before first study drug administration and until donating the last sample of the study.
* Participant does not agree to not taking any vitamins taken for nutritional purposes within at least two days before first study drug administration and until donating the last samp…
What they're measuring
1
Cmax (Maximal Plasma Concentration)
Timeframe: 48.00 hours
2
AUC0-t (Area Under the plasma concentration-time Curve from zero (0) hours to time (t) hours)