| CTRI Number |
CTRI/2015/09/006176 [Registered on: 11/09/2015] Trial Registered Retrospectively |
| Last Modified On: |
28/08/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioavailability of Methylcobalamin Sublingual tablet 1500 mcg in healthy human volunteers. |
|
Scientific Title of Study
|
An open-label single-dose, randomized, four-period, four-treatment, four sequence, four-way
crossover, comparative bioavailability study of 1500 mcg Methylcobalamin Sublingual tablets of
Troikaa Pharmaceuticals Ltd. in 12 healthy adult subjects under fasting condition. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ARL-BA-175-METH-2015, Version 01, dated 06-02-2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pankaj Bablani |
| Designation |
Principal Investigator |
| Affiliation |
Auriga Research Limited |
| Address |
Auriga Research Limited
3/15, Kirti Nagar Industrial Area,
New Delhi
New Delhi
DELHI
110015
India |
| Phone |
|
| Fax |
|
| Email |
drpankajbablani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Paliwal |
| Designation |
Medical Advisor |
| Affiliation |
Troikaa Pharmaceuticals Limited |
| Address |
Commerce House I
Opp. Rajvansh Appartment
Satya Marg
Bodakdev
Ahmadabad
GUJARAT
380054
India |
| Phone |
|
| Fax |
|
| Email |
jyotikumar@troikaapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Maroo |
| Designation |
Sr General Manager |
| Affiliation |
Troikaa Pharmaceuticals Limited |
| Address |
Commerce House I
Opp. Rajvansh Appartment
Satya Marg
Bodakdev
Ahmadabad
GUJARAT
380054
India |
| Phone |
|
| Fax |
|
| Email |
sanjaymaroo@troikaapharma.com |
|
|
Source of Monetary or Material Support
|
| Troikaa Pharmaceuticals Ltd |
|
|
Primary Sponsor
|
| Name |
Troikaa Pharmaceuticals Ltd |
| Address |
Commerce House I, Opp. Rajvansh Appartment, Satya Marg, Bodakdev, Ahmedabad |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pankaj Bablani |
Auriga Research Ltd |
3/15, Kirti Nagar Industrial Area,
New Delhi - 110015
New Delhi
DELHI |
011-45754546
pankaj.bablani@aurigaresearch.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Good Society for Ethical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Methylcobalamin Sublingual tablets 1500 mcg |
Dose: 1500 mcg
Frequency: Single dose
Route of Administration: Sublingual
3 versions of Methylcobalamin Sublingual tablet |
| Intervention |
Methylcobalamin Sublingual Tablets 1500 mcg |
Dose: 1500 mcg
Frequency: Single dose
Route of Administration: Sublingual |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
• 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. |
|
| ExclusionCriteria |
| Details |
• 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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| Tmax, Kel, T1/2, |
NA |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
30/07/2015 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 |