Bioavailability of Methylcobalamin Sublingual tablet 1500 mcg in healthy human volunteers.
- Registration Number
- CTRI/2015/09/006176
- Lead Sponsor
- Troikaa Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 12
• 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
by
- 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
study.
• 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.
• 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
consent.
• 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
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method