CTRI/2019/01/016937已完成未知
A randomized, double blind, placebo controlled, dose-response relationship study toinvestigate the efficacy of Fructo-oligosaccharides (FOS) on human gut microflorafollowing oral doses of fructo-oligosaccharides of TATA Chemicals Ltd., India in healthy,adult, human subjects.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1.Subjects aged between 18 and 55 years (both inclusive).
- •2.Subjects weight within normal range according to normal values for Body Mass Index (18.50 to 30.00 kg/m2) with minimum of 45 kg weight.
- •3.Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations (Annexure IIIa) within the clinically acceptable reference range (Annexure IIIb).
- •4.Subjects having clinically accepted 12-lead electrocardiogram (ECG).
- •5.Subjects having clinically accepted chest X-Ray (PA view).
- •6.Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- •7.Subjects having negative alcohol breath test.
- •8.Subjects willing to adhere to the protocol requirements and to provide written informed consent.
- •9. Subjects having negative urine pregnancy test at screening and on admission day 01 of basal phases (only for female subjects).
- •10. For Female Subjects:
- •Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence, or
- •Postmenopausal for at least 1 year, or
- •Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
排除标准
- •Hypersensitivity to Fructo-oligosaccharides or Maltodextrin or related class of drugs or any of its excipients or to heparin.
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month prior to day 01 of basal phases.
- •History or presence of significant alcoholism or drug abuse.
- •History or presence of significant smoking (more than 10 cigarettes or beedis/day).
- •History or presence of asthma, urticaria or other significant allergic reactions.
- •History or presence of significant gastric and/or duodenal ulceration.
- •History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- •History or presence of cancer.
- •Difficulty with donating blood.
- •Use of any prescribed medication during last one month or OTC medication during last two weeks prior to day 01 of basal phases.
- •Major illness within past 3 months.
- •Volunteer who have donated blood (1 unit) within 90 days prior to the first dose of the study drug or have blood loss, excluding volume drawn at screening (more than 100 ml within 30 days; more than 200 ml within 60 days) prior to day 01 of basal phases of the study or have received a known investigational drug within five elimination half life of the administered drug prior to the first dose of the study drug.
- •Consumption of grapefruit juice, xanthine-containing products, tobacco containing products or alcohol within 48 hours prior to day 01 of basal phases.
- •Positive screening test result for any one or more: HIV, Hepatitis B and Hepatitis C.
- •History or presence of significant easy bruising or bleeding.
- •History or presence of significant recent trauma.
- •Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
- •Female subjects who are currently breast feeding.
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