| CTRI Number |
CTRI/2018/05/013839 [Registered on: 11/05/2018] Trial Registered Prospectively |
| Last Modified On: |
09/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Other |
|
Public Title of Study
|
A relative Bioavailability study to understand the absorption of 2 different formulations of Vitamin D3 available in Indian Market |
|
Scientific Title of Study
|
A Randomized,Open Label, Balanced, Two Treatment, Two period, Two Sequence, Single Dose, Crossover, Relative Bioavailability Study of Depura 5mL (60,000 IU) Oral Solution of Sanofi India Ltd, with Uprise D3 (Cholecalciferol) 60,000 IU capsule of Alkem Pharma, in Normal, Healthy, Adult, Male and Female Human Subjects under Fasting Conditions. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CHOLE07832,Study code ARL/17/562,Version 01, Feb 16,2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Santosh Kale |
| Designation |
Principal Investigator |
| Affiliation |
Accutest Research Laboratories Pvt Ltd |
| Address |
Accutest Research Laboratories Pvt Ltd
A 31 MIDC
TTC Industrial Area
Khairane
Navi Mumbai
Mumbai
MAHARASHTRA
400709
India |
| Phone |
912227780718 |
| Fax |
912227780720 |
| Email |
santosh.kale@accutestglobal.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Verma |
| Designation |
Head of Medical Affairs CHC South Asia Zone |
| Affiliation |
Sanofi India Limited |
| Address |
Sanofi India Limited
CTS No 117 oblique B
L and T Business Park
Saki Vihar Rd
Powai Mumbai
Mumbai
MAHARASHTRA
400072
India |
| Phone |
02228032072 |
| Fax |
02228032846 |
| Email |
drmanish.verma@sanofi.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Ajit Walekar |
| Designation |
Records Specialist |
| Affiliation |
Sanofi India Ltd |
| Address |
Sanofi India Limited
Sanofi House C TS No 117 oblique B
L and T Business Park
Saki Vihar Rd
Powai
Mumbai
Mumbai
MAHARASHTRA
400072
India |
| Phone |
02228032824 |
| Fax |
02228032846 |
| Email |
ajit.walekar@sanofi.com |
|
|
Source of Monetary or Material Support
|
| Sanofi India Limited
Sanofi House
CTS No 117 oblique B
L and T Business Park
Saki Vihar Road
Powai
Mumbai 400072 |
|
|
Primary Sponsor
|
| Name |
Sanofi Synthelabo India Private Limited |
| Address |
CTS No 117 oblique B
L and T Business Park
Saki Vihar Rd
Powai
Mumbai 400072 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Santosh Kale |
Accutest Research Laboratories India Pvt Ltd |
Accutest Research Laboratories India Pvt Ltd A31
MIDC TTC Industrial Area
Khairane
Navi Mumbai 400709
Mumbai
MAHARASHTRA |
912227780718
912227780720
santosh.kale@accutestglobal.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Care Independent Ethics Committee Shop No 04 Chandresh Krishna Near Nilje Railway Station Kalyan Shil Road Lodha Heaven Dombivali East Thane 421 204 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Vitamin D deficiency |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Depura 5mL of 60000 IU Oral Solution |
Dosage Form
Oral Solution
Formulation strength
Depura Oral Solution containing Cholecalciferol 60000 IU
Dose 1 of 5mL
|
| Comparator Agent |
Uprise D3 Soft gelatin capsule |
Dosage Form
Soft gelatin capsule
Formulation strength Cholecalciferol 60000 IU
Dose
1of 60,000 IU Soft gelatin capsule
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1 Male or non-pregnant female human subjects age in the range of 18 to 45 years both inclusive
2 Body mass index within the range of 18.5 kg per m2 to 24.99 kg per m2 extremes included
3 Subjects with a base line 25 hydroxy vitamin D level between 10-20ng per ml extremes included
4 Subjects with normal findings as determined by baseline history
physical examination
vital sign examination of blood pressure
pulse rate
respiration rate
axillary temperature
5 Subjects with clinically acceptable findings as determined by
haemogram
biochemistry
urinalysis
12 lead ECG
chest X-rayif done
6 Subjects free from signs or symptoms suggestive of upper GI disorders including oral cavity
7 Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages like chocolates
tea
coffee
or cola drinks
or grapefruit juice
any alcoholic products
the use of cigarettes and tobacco products for 48 hrs prior to dosing until after the last blood sample collection in each study period and adherence to
food
fluid
and posture restrictions
8 No history of alcohol dependence
9 No history of drug abuse like benzodiazepines and barbiturates for the last one month and other illegal drugs as per Appendix Bfor the last 06 months
10Non-smokers
Ex-smokers
and moderate smokers will be included
Moderate smokers are defined as someone smoking 10 cigarettes or less per day and ex-smokers are someone who completely stopped smoking for at least 3 months
11 Note
Moderate smokers would have to abstain from smoking for 48hours prior and after dosing
12 Subjects agreeing to avoid direct exposure to sunlight during the period of blood sample collection in each study period
13 Having given written informed consent prior to undertaking any study-related procedure
14 Covered by a health insurance system where applicable, and oblique or in compliance with the recommendations of the national laws in force relating to biomedical research
15 Not under any administrative or legal supervision.
|
|
| ExclusionCriteria |
| Details |
1 Known history of hypersensitivity to Cholecalciferol
ergocalciferol or Vitamin D metabolites like eg calcitriol
calcifediol
alfacalcidol
calcipotriol
or related drugs
2 Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days prior to dosing day
3 Subjects who have taken prescription medications or over the counter products including vitamins like including any type of vitamin D and minerals within 14 days prior to administration of Investigational Product
4 Any medical or surgical conditions which might significantly interfere with the functioning of gastrointestinal tract blood forming organs etc
5 History of cardiovascular
renal
hepatic
ophthalmic
pulmonary
neurological
metabolic
haematological
gastrointestinal
endocrine
immunological or psychiatric diseases
6 Participation in a clinical drug study or BE study 90 days prior to period I dosing of the present study
7 History of malignancy or other serious diseases
8 Blood donation 90 days prior to period I dosing of the present study
9 Subjects with positive HIV tests or HBsAg or Hepatitis-C tests
10 History of problem in swallowing
11 Any contraindication to blood sampling
12 Found positive in breath alcohol test
13 Found positive in urine test for drug abuse
14 Found positive serum β Beta hCG Human Chorionic Gonadotropin test
15 Pregnant defined as positive β HCG blood test or lactating women currently breast feeding
16 Female subjects not confirming to using birth control measures from the date of screening until the completion of the study
Abstinence barrier methods like condom
diaphragm etc are acceptable
17 Use of hormonal contraceptives either oral or implants about two weeks prior to first dosing until end of clinical phase which is Last period last PK sample
18 Patients with Hypercalcemia or hypercalciuria
19 Patients with Nephrolithiasis or Nephrocalcinosis
20 Patients with Hypervitaminosis D
21 Subjects with lipid malabsorption and associated disorders
22 Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study or unable to cooperate because of a language problem or poor mental development
23 Any subject who cannot be contacted in case of emergency
24 Any subject who is the Investigator or any subinvestigator
research assistant
pharmacist
study coordinator
or other staff thereof
directly involved in conducting the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the AUC 0 to 120 of Test Product Depura 5mL of 60,000 IU as Oral Solution as T with one other Reference Product Uprise D3 Soft gelatin capsules as R in Healthy
Adult
Male And Female
Human Subjects under Fasting Condition |
5 minutes prior to dosing and 1,2,4,6,8,10,15,24,36,48,72,96 and 120 hours post dosing |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor the safety and tolerability of a single oral dose of investigational products IPs
To compare the Cmax and Tmax of Test Product Depura Oral Solution as T with one other Reference Product Uprise D3 Soft gelatin capsules as R in Normal
Healthy
Adult
Male And Female
Human Subjects under Fasting Condition
|
5 minutes prior to dosing and 1,2,4,6,8,10,16,24,36,48,72,96 and 120 hours post dosing
|
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/05/2018 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
study is a Randomized, Open Label, Balanced, Two Treatment, Two period, Two
Sequence, Single Dose, Crossover, Relative Bioavailability Study to compare the
absorption of Vitamin D from 2 different formulations available in the Indian
Market.
The Primary objective is to compare the AUC
0-120 and the secondary
objective is to monitor the safety and tolerability of a single oral dose of
investigational products (IPs) and to compare the Cmax and Tmax
of Test Product: Depura Oral Solution (T) with one other Reference
Product Uprise D3 Soft gelatin capsules (R) in Normal, Healthy, Adult, Male And
Female, Human Subjects under Fasting Condition. |