NCT07278349已完成1 期
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 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年9月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Cmax (Maximal Plasma Concentration)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •Participant does not agree to not consuming any beverages or food containing grapefruit at least 2 weeks prior to first study drug administration until donating the last sample of the study.
- •Participant has a history of severe diseases which have direct impact on the study.
- •Participation in a bioequivalence study or in a clinical study within the last 80 days before first study drug administration.
- •Participant intends to be hospitalized within 3 months after first study drug administration.
- •Participants who donated blood or its derivatives in the past 3 months or who through completion of this study, would have donated more than 1250 ml in 120 days, 1500 ml in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year.
- •Participant has a history of significant asthma, peptic or gastric ulcer, sinusitis, pharyngitis, renal disorder (impaired renal function), hepatic disorder (impaired hepatic function), cardiovascular disorder, neurological disease such as epilepsy, haematological disorders or diabetes, psychiatric, dermatologic or immunological disorders.
- •Participant does not agree to not be engaged in strenuous exercise at least one day prior to study drug administration until donating the last sample in each respective period.
- •Participant having at screening examination a pulse outside the normal range of (60-100 beats per minute) or a body temperature outside the normal range of (35.0-37.2 °C) or a respiratory rate outside the normal range of (12-20 breaths per minute) or a sitting blood pressure less than 100/60 mm Hg or more than or equal to 140/90 mm Hg.
- •Participant has history of difficulties in swallowing or any gastrointestinal disease which could affect the drug absorption.
- •Positive blood screen for HIV, Hepatitis B surface antigen (HBsAg), or Hepatitis C.
- •Participant has a difficulty fasting or consuming standard meals.
- •The participant is a pregnant or lactating female.
- •Participant does not agree to not consuming any medication or food which may affect CYP3A4/5, CYP2B6, CYP2C19, CYP2C9 and CYP2D6 enzymes at least two weeks prior to first study drug administration until donating the last sample of the study.
研究组 & 干预措施
VONOPRAZAN FILM COATED TABLETS
Experimental
VONOPRAZAN FILM COATED TABLETS (20 mg Vonoprazan)
干预措施: Vonoprazan Tablets (Drug)
VONOPRAZAN FILM COATED TABLETS
Experimental
VONOPRAZAN FILM COATED TABLETS (20 mg Vonoprazan)
干预措施: VOQUEZNA® Tablets (Drug)
VOQUEZNA® (VONOPRAZAN) TABLETS
Active Comparator
VOQUEZNA® (VONOPRAZAN) TABLETS (20 mg Vonoprazan)
干预措施: Vonoprazan Tablets (Drug)
VOQUEZNA® (VONOPRAZAN) TABLETS
Active Comparator
VOQUEZNA® (VONOPRAZAN) TABLETS (20 mg Vonoprazan)
干预措施: VOQUEZNA® Tablets (Drug)
结局指标
主要结局
Cmax (Maximal Plasma Concentration)
时间窗: 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)
时间窗: 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%
次要结局
- 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)
研究者
研究点 (1)
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