An Open-label, Single-Dose, Three-way Crossover Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents (12 to 17 Years of Age) and Young Adults (18 to 24 Years of Age) With Seasonal Allergic Rhinitis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Sandoz
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Tmax
研究概览
简要总结
This study will compare the PK parameters of the combination test formulation to monotherapy reference products (mometasone furoate and azelastine hydrochloride) in adolescents and young adult patients with seasonal allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-smoking, adolescent or young adult male and female subjects with seasonal allergic rhinitis.
- •Willing to use acceptable, effective methods of contraception.
- •Be informed of the nature of the study and give written consent (adults) / assent and consent by legal guardian(s)/parent(s) (adolescents) prior to any study procedure.
排除标准
- •Known history or presence of clinically significant disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- •Known history or presence of hypersensitivity or idiosyncratic reaction to mometasone, azelastine, or any other drug substances with similar activity.
- •Unable to tolerate direct venipuncture.
- •Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
- •Positive test result for urine drugs of abuse or urine cotinine.
- •Presence of nostril or septum piercing.
- •Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
- •Females who are pregnant, breast-feeding, or have used hormonal contraceptives within 21 days (oral and transdermal) or 6 months (implanted, injected, intravaginal, or intrauterine) prior to drug administration.
- •Donation or loss of whole blood (including clinical trials) within 30 days prior to drug administration (or 56 days for ≥500 mL).
- •Participation in a clinical trial that involved administration of an investigational medicinal product within 30 days prior to drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results.
- •Received any type of live vaccine within 30 days prior to drug administration.
- •Use of medication within 30 days prior to drug administration.
- •On a special diet within 30 days prior to drug administration.
- •Have had a tattoo or body piercing within 30 days prior to drug administration.
研究组 & 干预措施
Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine
干预措施: Mometasone Furoate (Drug)
Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride
干预措施: Mometasone + Azelastine (Drug)
Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride
干预措施: Mometasone Furoate (Drug)
Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride
干预措施: Azelastine Hydrochloride (Drug)
Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine
干预措施: Mometasone + Azelastine (Drug)
Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine
干预措施: Azelastine Hydrochloride (Drug)
Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate
干预措施: Mometasone + Azelastine (Drug)
Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate
干预措施: Mometasone Furoate (Drug)
Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate
干预措施: Azelastine Hydrochloride (Drug)
结局指标
主要结局
Tmax
时间窗: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Time of the maximum measured analyte concentration over the sampling period.
AUCt
时间窗: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
The area under the analyte concentration versus time curve, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear up/log down variant of the trapezoidal method.
Cmax
时间窗: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Maximum measured analyte concentration over the sampling period.
Kel
时间窗: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
The apparent first-order elimination rate constant
AUCinf
时间窗: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
The area under the analyte concentration versus time curve from time zero to infinity. AUCinf = AUCt + Ct/Kel, where Ct is the last measurable analyte concentration.
Thalf
时间窗: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
The apparent elimination half-life
次要结局
未报告次要终点