None listed
Conditions
Interventions
Intervention1: Methylcobalamin Sublingual Tablets 1500 mcg: Dose: 1500 mcg
Frequency: Single dose
Route of Administration: Sublingual
Control Intervention1: Methylcobalamin Sublingual tablets 1500 mcg
Sponsors
Troikaa Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t, AUC0-infTimepoint: -10.00, -06.00, Pre-dose (collected within 1 hour prior to drug administration) and at 05, 15, 30, 45 min, and 1.00, 1.50, 2.00, 3.00, 5.00, 8.00, 12.00, 16.00, 24.00 hours (post dose). | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, Kel, T1/2,Timepoint: NA | — |
Countries
India
Contacts
Public ContactDr Sanjay Maroo
Troikaa Pharmaceuticals Limited
Outcome results
None listed