CTRI/2015/09/006176进行中（未招募）1 期
An open-label single-dose, randomized, four-period, four-treatment, four sequence, four-waycrossover, comparative bioavailability study of 1500 mcg Methylcobalamin Sublingual tablets ofTroikaa Pharmaceuticals Ltd. in 12 healthy adult subjects under fasting condition.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
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
- •Male or female subjects in the age range of 18-45 years (including both).
- •If female subjects and;
- •Of child bearing potential but practicing acceptable method of contraception or surgically sterile. Acceptable methods of contraception are:
- •- Intra-uterine contraceptive device without hormone release system (placed at least 4 weeks prior to study drug administration;
- •- Effective method of barrier contraception like Condom or diaphragm with spermicidal
- •gel/foam/film/cream/suppository or
- •Postmenopausal status of at least I year. The post menopausal status should be confirmed
- •- No vaginal bleeding for at least I year.
- •BMI range within 18.00 - 25.00.Kg/m2 (including both).
- •Subject with serum total B12 level range of 200 pg/mL to 900 pg/mL.
- •Have voluntarily given written informed consent to participate in this study.
- •Be of normal health as determined by medical history, physical examination and laboratory
- •investigations of the subjects performed within 21 days prior to the commencement of the
- •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.
排除标准
- •Hypersensitivity and/ or intolerance to Methylcobalamin, cobalt, or any of its excipients or other related group of drugs.
- •History of pancreatitis or hepatitis or gastritis or gastrointestinal ulcer/ bleeding or Melena or hematemesis
- •History of drug induced rash, anaphylaxis and photosensitivity reaction.
- •History of seizures.
- •History of chest pain
- •History of any psychiatric illness which may impair the ability to provide written informed
- •Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
- •Presence of disease markers of HIV 1 and 2, Hepatitis B and C viruses or syphilis infection.
- •Laboratory values that are significantly different from the normal reference range and/or are deemed to be of clinical significance by the investigator
- •Clinically abnormal ECG or Chest X-ray.
- •Systolic blood pressure less than 100 mm Hg or more than or equal to 140 mm Hg.
- •Diastolic blood pressure less than 60 mm Hg or more than or equal to 90 mm Hg.
- •Pulse rate less than 60 beats /minute or more than equal to 100 beats /minute.
- •Difficulty with donating blood.
- •History of Smoking (positive history of smoking from last one year).
- •History of drug dependence or alcoholics (positive history of alcohol intake from last one year).
- •History of dehydration from diarrhea, vomiting or any other reason within a period of 24.0 hours prior to study check-in of each period.
- •Use of any enzyme modifying drugs, MAOis and other prescription drugs within 30 days prior to Day 1 of this study or use of any other over the counter medications (OTC drug) during the 2 weeks period prior to the onset of study.
- •Participation in any clinical trial within 12 weeks preceding Day 1 of this screening.
- •Subjects who, through completion of this study, would have donated and/or lost more than
- •500 mL of blood in the past 3 months.
- •Female subjects of childbearing potential having unprotected sexual intercourse with any
- •non-sterile male partner (i.e. male who has not been sterilized by vasectomy for at least 6
- •months) within 14 days prior to study drug administration.
- •Positive urine pregnancy test at screening.
- •Breast-feeding subject
研究者
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