CTRI/2018/05/013839尚未招募未知
A Randomized,Open Label, Balanced, Two Treatment, Two period, Two Sequence, Single Dose, Crossover, Relative Bioavailability Study of Depura 5mL (60,000 IU) Oral Solution of Sanofi India Ltd, with Uprise D3 (Cholecalciferol) 60,000 IU capsule of Alkem Pharma, in Normal, Healthy, Adult, Male and Female Human Subjects under Fasting Conditions. - NA
Sanofi Synthelabo India Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
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 Male or non-pregnant female human subjects age in the range of 18 to 45 years both inclusive
- •2 Body mass index within the range of 18.5 kg per m2 to 24.99 kg per m2 extremes included
- •3 Subjects with a base line 25 hydroxy vitamin D level between 10-20ng per ml extremes included
- •4 Subjects with normal findings as determined by baseline history
- •physical examination
- •vital sign examination of blood pressure
- •respiration rate
- •axillary temperature
- •5 Subjects with clinically acceptable findings as determined by
- •biochemistry
- •12 lead ECG
- •chest X-rayif done
- •6 Subjects free from signs or symptoms suggestive of upper GI disorders including oral cavity
- •7 Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages like chocolates
- •or cola drinks
- •or grapefruit juice
- •any alcoholic products
- •the use of cigarettes and tobacco products for 48 hrs prior to dosing until after the last blood sample collection in each study period and adherence to
- •and posture restrictions
- •8 No history of alcohol dependence
- •9 No history of drug abuse like benzodiazepines and barbiturates for the last one month and other illegal drugs as per Appendix Bfor the last 06 months
- •10Non-smokers
- •Ex-smokers
- •and moderate smokers will be included
- •Moderate smokers are defined as someone smoking 10 cigarettes or less per day and ex-smokers are someone who completely stopped smoking for at least 3 months
- •Moderate smokers would have to abstain from smoking for 48hours prior and after dosing
- •12 Subjects agreeing to avoid direct exposure to sunlight during the period of blood sample collection in each study period
- •13 Having given written informed consent prior to undertaking any study-related procedure
- •14 Covered by a health insurance system where applicable, and oblique or in compliance with the recommendations of the national laws in force relating to biomedical research
- •15 Not under any administrative or legal supervision.
排除标准
- •1 Known history of hypersensitivity to Cholecalciferol
- •ergocalciferol or Vitamin D metabolites like eg calcitriol
- •calcifediol
- •alfacalcidol
- •calcipotriol
- •or related drugs
- •2 Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days prior to dosing day
- •3 Subjects who have taken prescription medications or over the counter products including vitamins like including any type of vitamin D and minerals within 14 days prior to administration of Investigational Product
- •4 Any medical or surgical conditions which might significantly interfere with the functioning of gastrointestinal tract blood forming organs etc
- •5 History of cardiovascular
- •neurological
- •haematological
- •gastrointestinal
- •immunological or psychiatric diseases
- •6 Participation in a clinical drug study or BE study 90 days prior to period I dosing of the present study
- •7 History of malignancy or other serious diseases
- •8 Blood donation 90 days prior to period I dosing of the present study
- •9 Subjects with positive HIV tests or HBsAg or Hepatitis-C tests
- •10 History of problem in swallowing
- •11 Any contraindication to blood sampling
- •12 Found positive in breath alcohol test
- •13 Found positive in urine test for drug abuse
- •14 Found positive serum β Beta hCG Human Chorionic Gonadotropin test
- •15 Pregnant defined as positive β HCG blood test or lactating women currently breast feeding
- •16 Female subjects not confirming to using birth control measures from the date of screening until the completion of the study
- •Abstinence barrier methods like condom
- •diaphragm etc are acceptable
- •17 Use of hormonal contraceptives either oral or implants about two weeks prior to first dosing until end of clinical phase which is Last period last PK sample
- •18 Patients with Hypercalcemia or hypercalciuria
- •19 Patients with Nephrolithiasis or Nephrocalcinosis
- •20 Patients with Hypervitaminosis D
- •21 Subjects with lipid malabsorption and associated disorders
- •22 Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study or unable to cooperate because of a language problem or poor mental development
- •23 Any subject who cannot be contacted in case of emergency
- •24 Any subject who is the Investigator or any subinvestigator
- •research assistant
- •study coordinator
- •or other staff thereof
- •directly involved in conducting the study
研究者
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