An open label, randomized, balanced, two-period, two-treatment, cross over, single dose oral bioavailability study of FLAVOSPRINT 500 PRO (containing microSMIN PLUS) (T) of GIELLEPI S.p.A., and FLAVOSPRINT (containing micronized diosmin) (R) of GIELLEPI S.p.A. in healthy, adult, human subjects under fasting conditions.

GIELLEPI0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 未知
状态: 尚未招募
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•1. Healthy, adult, human subjects aged between 18 and 45 years (both inclusive) weighing at least 50 kg at the time of screening.
•2. Having a Body Mass Index (BMI) between 18.50 and 24.99 kg/m2 (both inclusive) at the time of screening.
•3. Normal or clinically insignificant findings during screening, medical history, medical examination, laboratory evaluations, 12 lead ECG and X-ray chest (postero-anterior view) recordings.
•4. Able to comply with the study procedures, in the opinion of the principal investigator.
•5. Compliance with study specific restrictions and prohibitions.
•6. Able to give voluntary written informed consent for participation in the trial.
•7. In case of Female subjects:
•a)Female subjects who are of child bearing potential and are surgically sterilized at least 6 months prior to study participation.
•b)Female subjects who are of child bearing potential and are willing to use a suitable and effective double barrier contraceptive method or non-hormonal intra uterine device during the study.
•c)Female subjects who are tested negative for urine pregnancy test at the time of screening and serum pregnancy test at the time of check-in of period-I.
•d)Female subjects who has surgically sterilized partner (for at least 6 months).
•e)Female subjects who are post-menopausal for at least 2 years.

排除标准

•1. Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.
•2. History of allergic reaction to heparin.
•3. History or presence of any disease or disorder known to influence bone metabolism, compromise the hemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, musculoskeletal or any other body system.
•4. Systolic blood pressure less than 90 mmHg or more than 140 mmHg at the time of screening. Minor deviations (2-4 mmHg) may be acceptable at the discretion of the physician/investigator.
•5. Diastolic blood pressure less than 60 mmHg or more than 90 mmHg at the time of screening. Minor deviations (2-4 mmHg) may be acceptable at the discretion of the physician/investigator.
•6. Pulse rate below 60 beats / minute or above 100 beats / minute at the time of screening.
•7. Oral temperature below 96.2o F or above 99.8 o F at the time of screening.
•8. Ingestion of any medicine at any time within 14 days prior to IP administration in period I. In any such case subject selection will be at the discretion of the principal investigator.
•9. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria.
•10. A recent history of alcoholism ( < 2 years) or daily consumption of moderate (180 mL/day) alcohol use, or consumption of alcohol or alcoholic products within 48 hours prior to administration of test or reference product till the end of each period.
•11. Current smokers, who smoke 10 or more cigarettes/day or are unable to abstain from smoking 24 hours before administration of test or reference product till completion of the study.
•12. The presence of clinically significant abnormal laboratory values during screening.
•13. Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and alcohol breath analysis.
•14. A history of difficulty with donating blood or having donated blood in the preceding 90 days prior to the start of the study.
•15. Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the 90 days preceding the start of the study.
•16. Difficulty in swallowing capsule/tablet.
•17. Positive HIV, VDRL/RPR, Hepatitis B and C tests.
•18. Subjects who have used any drugs or substances known to be strong inhibitors or inducers of Cytochrome P450 enzymes within 14 days prior to IP administration in period I.
•19. Female subjects who demonstrates a positive pregnancy during screening or currently breast-feeding.

研究者

发起方

GIELLEPI

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