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临床试验/CTRI/2025/10/095585
CTRI/2025/10/095585已完成不适用

An open label, randomized, two-treatment, four-period, four-sequence, single dose, crossover study to investigate the potential food effect on the oral bioavailability of Fexofenadine Hydrochloride 30 mg and 60 mg Chewable Tablet in healthy adult human participants.

Opella Healthcare Group SAS1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年10月27日最近更新:
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试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
To assess the effect of food (high-fat breakfast) on the bioavailability of a 30 and 60 mg Fexofenadine Hydrochloride Chewable Tablet
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

An open label, randomized, two-treatment, four-period, four-sequence, single dose, crossover study to investigate the potential food effect on the oral bioavailability of Fexofenadine Hydrochloride 30 mg and 60 mg Chewable Tablet in healthy adult human participants.

Objectives:

a. To assess the effect of food (high-fat breakfast) on the bioavailability of a 30 and 60 mg Fexofenadine Hydrochloride Chewable Tablet.

b. To assess the clinical safety of the Fexofenadine Hydrochloride 30 mg Chewable Tablet and Fexofenadine Hydrochloride 60 mg Chewable Tablet in fasting and fed conditions.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)（—）

入选标准

  • •Age: 18 to 55 years old, both inclusive.
  • •Gender: Male and/or non-pregnant, non-lactating female.
  • •Female of child-bearing potential must have a negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy test performed within 28 days of the first dose of study medication.
  • •They must be using an acceptable form of contraception.
  • •For female of childbearing potential, acceptable forms of contraception include the following: i.
  • •Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or ii.
  • •Barrier methods containing or used in conjunction with a spermicidal agent, or iii.
  • •Surgical sterilization or iv.
  • •Practicing sexual abstinence throughout the course of the study.
  • •Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history: i.
  • •Postmenopausal with spontaneous amenorrhea for at least one year, or ii.
  • •Spontaneous amenorrhea for more than 6 months and less than one year with Serum Follicular Stimulating Hormone (FSH) level greater than 40 mIU/mL, or iii.
  • •Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iv.
  • •Total hysterectomy and an absence of bleeding for at least 3 months.
  • •BMI: 18.5 to 30.0 kg/m2, both inclusive BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
  • •Male participant having body weight greater than or equals to 50 Kg and less than or equals to 100 Kg both inclusive and female participant having body weight greater than or equals to 40 Kg and less than 90 Kg both inclusive.
  • •Participant having normal vital signs after 10 minutes resting in supine position: A.
  • •95 mmHg less than systolic blood pressure (SBP) less than 140 mmHg B.
  • •50 bpm less than heart rate (HR) less than 100 bpm
  • •Participant having a normal or no clinically significant finding in 12-lead electrocardiogram (ECG) recording in supine position in the following ranges: Standard 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine position in the following ranges: 120 ms less than PR less than 220 ms, QRS less than 120 ms, QTcF less than or equals to 450 ms if male, less than or equals to 470 ms if female and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.
  • •Able to communicate effectively with study personnel.
  • •Willing to provide written informed consent to participate in the study.
  • •All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of study medication administration which will include: a.
  • •A physical examination (clinical examination) with no clinically significant finding.
  • •Hematology a.
  • •Hemoglobin b.
  • •Total RBC count c.
  • •Total WBC count d.
  • •Platelet count A.
  • •Differential leukocyte count: a.
  • •Neutrophils b.
  • •Lymphocytes c.
  • •Eosinophils d.
  • •Monocytes e.
  • •Basophils B.
  • •Blood indices: HCT
  • •Biochemistry a.
  • •Serum creatinine c.
  • •Random glucose d.
  • •SGPT and SGOT e.
  • •Alkaline phosphatase f.
  • •Uric acid g.
  • •Serum bilirubin A.
  • •Serum total protein: Total proteins, Albumin B.
  • •Serum electrolytes: Serum sodium, serum chloride, serum potassium, serum phosphorous, serum calcium
  • •Urinalysis: Color, quantity, specific gravity, odour, appearance, reaction, albumin, bilirubin, ketone bodies, sugar, urobilinogen and microscopical examination (performed based on clinical judgment)
  • •Immunological Tests a.
  • •HIV-I and II b.
  • •Additional tests and/or examinations (apart from mentioned in protocol) may be performed, if necessary, based on principal investigator discretion.
  • •All results will be assessed against the current laboratory normal ranges at the time of testing and a copy of the normal ranges used will be included in the study documentation.

排除标准

  • •History of allergic responses to Fexofenadine Hydrochloride or other related drugs, or any of its formulation ingredients.
  • •Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female participants)].
  • •Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
  • •History or presence of bronchial asthma.
  • •Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
  • •Use of any depot injection or implant of any drug within 3 months prior to the first dose of study medication.
  • •History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
  • •Smoker who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period.
  • •History of difficulty with donating blood or difficulty in accessibility of veins.
  • •A positive hepatitis screen (includes subtypes B and C).
  • •Participant who have received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
  • •Participant who have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or greater than 200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater.
  • •History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
  • •Intolerance to venipuncture
  • •Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the participants participation in this study.
  • •Institutionalized participant.
  • •Use of any prescribed medications (including ketoconazole, erythromycin, aluminum and magnesium containing antacids or any other antacid) within 14 days prior to the first dose of study medication.
  • •Use of citrus fruits or fruit juices containing citrus, seville orange, starfruit, pomegranate, apple, pineapple, or pomelo within 7 days prior to the first dose of study medication.
  • •Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
  • •Use of grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
  • •Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), cigarettes and tobacco containing products, recreational drugs, alcohol or other alcohol containing products within 48 hours prior to the first dose of study medication.
  • •Use of products containing St. Johns wort within 14 days prior to the first dose of study medication.
  • •Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
  • •Participants having difference in systolic blood pressure (greater than or equals to 20 mmHg) or diastolic blood pressure (greater than or equals to 10 mmHg) when measured supine and standing blood pressure prior to check-in period-I.
  • •Any participant who cannot be contacted in case of emergency.
  • •Participant who have received any vaccination and any biologics (antibody or its derivatives) within the last 28 days prior to the first dose of study medication.

结局指标

主要结局

To assess the effect of food (high-fat breakfast) on the bioavailability of a 30 and 60 mg Fexofenadine Hydrochloride Chewable Tablet

时间窗: Pharmacokinetics blood sampling: | Pre-dose (0.0 hour) and at 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0 and 48.0 hours post dose (Approx. 0.3 Week)

次要结局

  • To assess the clinical safety of the Fexofenadine Hydrochloride 30 mg Chewable Tablet and Fexofenadine Hydrochloride 60 mg Chewable Tablet in fasting and fed conditions(48.0 hours post dose (Approx. 0.3 Week))

研究者

发起方
Opella Healthcare Group SAS
申办方类型
Pharmaceutical industry-Global
责任方
Principal Investigator
主要研究者

Dr Dhruv Patel

Cliantha Research Limited

研究点 (1)

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