NCT07278349
Completed
Phase 1
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
Humanis Saglık Anonim Sirketi1 site in 1 country28 target enrollmentStarted: September 21, 2025Last updated:
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Humanis Saglık Anonim Sirketi
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Cmax (Maximal Plasma Concentration)
Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy participant, age 18 to 50 years, inclusive.
- •Body Mass Index (BMI) range5 is within 18.5 - 30 Kg/m
- •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 sample of the study.
- •Participant is on a special diet (for example participant is vegetarian).
- •Participant consumes large quantities of alcohol or beverages containing methyl-xanthines e.g. caffeine (coffee, tea, cola, energy drinks, chocolate etc.).
- •Participant does not agree to not consuming any beverages or food containing alcohol at least 2 weeks prior to first study drug administration until donating the last sample of the study.
- •Participant does not agree to not consuming any beverages or food containing methyl-xanthines e.g. caffeine (coffee, tea, cola, energy drinks, chocolate etc.) at least 24 hours prior to the study drug administration of either study periods until the end of confinement.
Arms & Interventions
VONOPRAZAN FILM COATED TABLETS
Experimental
VONOPRAZAN FILM COATED TABLETS (20 mg Vonoprazan)
Intervention: Vonoprazan Tablets (Drug)
VONOPRAZAN FILM COATED TABLETS
Experimental
VONOPRAZAN FILM COATED TABLETS (20 mg Vonoprazan)
Intervention: VOQUEZNA® Tablets (Drug)
VOQUEZNA® (VONOPRAZAN) TABLETS
Active Comparator
VOQUEZNA® (VONOPRAZAN) TABLETS (20 mg Vonoprazan)
Intervention: Vonoprazan Tablets (Drug)
VOQUEZNA® (VONOPRAZAN) TABLETS
Active Comparator
VOQUEZNA® (VONOPRAZAN) TABLETS (20 mg Vonoprazan)
Intervention: VOQUEZNA® Tablets (Drug)
Outcomes
Primary Outcomes
Cmax (Maximal Plasma Concentration)
Time Frame: 48.00 hours
The point estimate and the 90% confidence intervals of the mean values for the Test/Reference ratio were within the bioequivalence acceptable boundaries of 80.00-125.00%
AUC0-t (Area Under the plasma concentration-time Curve from zero (0) hours to time (t) hours)
Time Frame: 48.00 hours
The point estimate and the 90% confidence intervals of the mean values for the Test/Reference ratio were within the bioequivalence acceptable boundaries of 80.00-125.00%
Secondary Outcomes
- AUC0-∞ (Area Under the plasma concentration-time Curve from zero (0) hours to infinity (∞))(48.00 hours)
- Kel (Elimination Rate Constant )(48.00 hours)
- tmax (Time until maximum plasma concentration is reached )(48.00 hours)
- t½el (Plasma concentration half-life)(48.00 hours)
Investigators
Study Sites (1)
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