An Open Label Balanced Randomized Single Dose Two Treatment Three Sequence Three Period Cross Over Partial Replicate Reference scaled Oral Bioavailability Study Comparing Fexofenadine Hydrochloride Oral Suspension 180 mg/5 mL Manufactured by Fexofenadine Hydrochloride Oral Suspension 180 mg/5 mL Manufactured by XL Laboratories Pvt Ltd 430 DLF Towers Shivaji Marg New Delhi 110015 India with Telfast (Fexofenadine Hydrochloride) Tablets 180 mg Marketing Authorisation Holder Opella Healthcare UK Limited Trading as Sanofi 410 Thames Valley Park Drive Reading Berkshire RG6 1PT United Kingdom In Healthy Adult Human Subjects Under Fasting Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To assess the Bioavailability on Fexofenadine Hydrochloride Oral Suspension 180 mg/5 mL with Telfast tablets 180 mg
研究概览
简要总结
Enough volunteers shall be recruited in order to evaluate and start the study with at least 48 subjects, as this Bioavailability study will be conducted on healthy, adult, human subjects.
As per the discretion of Investigator, additionally a sufficient number of stand-by subjects will be included to ensure successful dosing of 48 subjects in period I.
Demographic data, medical and medication history, physical examination, 12 lead ECG, haematology, biochemistry, serology, urine routine analysis and additionally for females serum pregnancy test, hormone assay (FSH) will be done within 21 days and chest X-ray within 06 months prior to check-in.
In each period subjects will be housed in the clinical facility for at least 11.00 hours pre-dose to 24.00 hours post-dose and the washout period of at least 05 days from the successive dosing day.
After collection of blood samples from all the subjects at each time point, study personnel will place the collected samples in a thermo-insulated box containing wet ice and transfer the box to the sample processing room where the blood samples will be centrifuged at 4000 ± 50 RPM for 10 minutes at 02°C to 08°C to separate the plasma. Centrifugation will start within 30 minutes of the collection of samples, at each collection time-point. The resulting plasma will be equally transferred to pre-labeled polypropylene tubes into two aliquots.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Normal healthy adult human subjects of age between 18-45 years and Body Mass Index (BMI) ranges between 18.50 kg/m2 to 30.00 kg/m2 Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance Generally healthy as documented by 12-lead electrocardiogram (ECG), Chest X-Ray and clinical laboratory assessments Willing to consume Ovo lacto-vegetarian diet Willing to comply to all requirements of this study protocol as well as instructed by the study personnel Generally healthy as documented by gynaecological examination and breast examination Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to initiation of the study & a negative urine pregnancy test prior to check-in of each period.
排除标准
- •Evidence of allergy or known hypersensitivity to Fexofenadine Hydrochloride or its inactive ingredients Subjects with hepatic encephalopathy cholestasis myasthenia pre-existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease Any major illness in the last three months or any significant ongoing chronic medical illness Any disease or condition which might compromise the haemopoeitic gastrointestinal hepatic renal cardiovascular Musculoskeletal respiratory central nervous system Or any other body system presence of Diabetes Mellitus and Psychosis History of alcohol addiction or abuse Subjects who have taken any prescription medications within 14 days prior to study check-in and throughout the study Subject who had participated in any other study within the 90 days of check-in History of difficulty in swallowing accessibility of veins Positive results for urine screen of drugs of abuse alcohol test prior to check in.
结局指标
主要结局
To assess the Bioavailability on Fexofenadine Hydrochloride Oral Suspension 180 mg/5 mL with Telfast tablets 180 mg
时间窗: 22 blood samples | 00.00 hours, 00.25 hours, 00.50 hours, 00.75 hours, 01.00 hours, 01.25 hours, 01.50 hours, 01.75 hours, 02.00 hours, 02.33 hours, 02.67 hours, 03.00 hours, 03.50 hours, 04.00 hours, 04.50 hours, 05.00 hours, 06.00 hours, 08.00 hours, 10.00 hours, 12.00 hours, 16.00 hours and 24.00 hours
次要结局
- To monitor the palatability (Test Product) safety & tolerability of single dose administered in healthy adult human subjects under fasting conditions(22 blood samples)
研究者
Dr Pradeep T
Spinos Lifescience and Research Private Limited