CTRI/2015/04/005687已完成未知
A Randomized, Single Dose, Open Label, 2-Way Crossover Comparative Bioavailability Study of Mecobalamin Nasal Spray 250 mcg/0.05 mL with Methycobal Injection (Mecobalamin 100 mcg/0.2 mL Intramuscular Injection)inHealthy Human Subjects under Fasting Conditions. - Not applicable
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 18
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
- •i. Subjects should be in the range of 18 â?? 45 years of age.
- •ii. BMI according to Body Mass Index (BMI) table (Appendix A)(i.e.Kg/m2 Range 18.5 to 24.9.
- •iii. Subject with serum total B12 level range of 200 pg/mL to 900 pg/mL.
- •iv. Subjects with normal findings as determined by Baseline history, Physical
- •Examination and Vital Signs (Blood Pressure, Pulse Rate, Respiratory Rate and
- •Axillary Temperature).
- •v. Subjects with normal/ not significant laboratory values as determined by hematological
- •tests, biochemistry, urine analysis and ECG in correlation with clinical findings.
- •vi. Willingness to follow the protocol requirement as evidenced by written informed
- •vii. Agreeing to, not using or conforming to not having used any medication (prescription
- •and over the counter), including vitamins and minerals for 15 days prior to study &
- •during the course of the study.
- •viii. No history or presence of significant alcoholism.
- •ix. No history of drug abuse.
- •x. Non-smokers, ex smokers and moderate smokers will be included.â??Moderate smokers are defined as someone smoking 10 cigarettes or less per day, ex smokers are someone who completely stopped smoking for at least 3 months.
- •xi. All female subjects having negative urine pregnancy test prior to enrolling into the study. All female subjects who are of child bearing potential or those within the first two years of the onset of menopausal syndrome using acceptable methods of birth control. Acceptable birth control methods include Barrier methods such as diaphragm/condom with spermicide. Unacceptable methods include oral or implanted contraceptives.
排除标准
- •i. Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
- •ii. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract and of bloodâ??forming organs.
- •iii. History of Cardiovascular, Renal, Hepatic, Ophthalmic, Pulmonary, Neurological, Metabolic hematological, gastrointestinal, endocrine, immunological or Psychiatric Diseases.
- •iv. Participation in any other clinical drug study or Bio-Equivalence study 90 days prior to present study.
- •v. History of Malignancy or any other serious diseases.
- •vi. Refusal to abstain from hot fluid and hot meal for one (1) hour prior to study drug administration on first day of each study period and for one (1) additional hour, post dosing, in each study period.
- •vii. Refusal to abstain from food for ten (10) hours prior to study drug administration on day 1 and four (4) additional hours post dose, for all the study periods.
- •viii. Any contraindication to blood sampling.
- •ix. Refusal to abstain from smoking or consumption of tobacco products 72 hrs before dosing until after the last blood sample collection in each study period.
- •x. Use of Xanthine-containing food or beverages (chocolates, tea, coffee or cola drinks)or grapefruit juice and any alcoholic products, for 48 hrs prior to dosing until after the last blood sample collection in each study period.
- •xi. Blood donation within 90 days prior to the commencement of the study.
- •xii. Subjects with positive HIV tests, Australia Antigen or Hepatitis-C tests.
- •xiii. Positive urine screen for drugs of abuse and breath alcohol test done during preenrolment
- •xiv. Subject with nasal polyp, running nose, nasal congestion, allergic rhinitis or respiratory tract infection.
- •xv. Known hypersensitivity to Mecobalamin.
- •xvi. Use of Vitamin B12 for 72 hours before dosing of each period.
- •xvii.Female subjects whose menstruation cycle coincides with the study dates.
研究者
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