Bioavailability of Methylcobalamin Sublingual tablet 1500 mcg in healthy human volunteers.

Phase 1

Active, not recruiting

• Conditions: Healthy Human Volunteers

• Registration Number: CTRI/2015/09/006176
• Lead Sponsor: Troikaa Pharmaceuticals Ltd

Brief Summary

This is a single-dose, randomized, four-period, four-treatment, four sequence, four-way crossover study in 12 healthy subjects. Primary objective of this study is to determine comparative bioavailability of four test formulations of Methylcobalamin Sublingual tablet 1500 mcg of Troikaa Pharmaceuticals Ltd. Secondary objective is to monitor safety of participating subjects

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-30
• Last Update Posted: 2015-08-28

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 12

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

• • 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
Cmax, AUC0-t, AUC0-inf	-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 Outcome Measures

Name	Time	Method
Tmax, Kel, T1/2,	NA

Trial Locations

Locations (1)

Auriga Research Ltd; 🇮🇳 Delhi, DELHI, India

Auriga Research Ltd

🇮🇳Delhi, DELHI, India

Dr Pankaj Bablani

Principal investigator

011-45754546

pankaj.bablani@aurigaresearch.com