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CTRI Number  CTRI/2021/10/037407 [Registered on: 20/10/2021] Trial Registered Prospectively
Last Modified On: 28/10/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to evaluate the effect of Aqueous Cholecalciferol injection in Vitamin-D deficient, but otherwise healthy, adult human subjects. 
Scientific Title of Study   A randomized, open-label, two-treatment, single-dose, parallel, comparative, pharmacokinetic (PK)/pharmacodynamic (PD) study to evaluate Aqueous Cholecalciferol injection 6,00,000 IU/2mL of Cadila Pharmaceuticals Limited, India with marketed Cholecalciferol 600000 IU oil-based injection in Vitamin-D deficient, but otherwise healthy, adult human subjects under fed condition. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
21-006 Version 01 date 08/06/2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjay Patel 
Designation  Asst. General Manager Cadila CRO  
Affiliation  Cadila Pharmaceuticals Limited 
Address  1389, Trasad Road Dholka, Ahmedabad
Dholka, Ahmedabad
Ahmadabad
GUJARAT
382225
India 
Phone  912714221481  
Fax    
Email  sanjay.p@cadilapharma.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Patel 
Designation  Asst. General Manager Cadila CRO  
Affiliation  Cadila Pharmaceuticals Limited 
Address  1389, Trasad Road Dholka, Ahmedabad
Dholka, Ahmedabad
Ahmadabad
GUJARAT
382225
India 
Phone  912714221481  
Fax    
Email  sanjay.p@cadilapharma.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sanjay Patel 
Designation  Asst. General Manager Cadila CRO  
Affiliation  Cadila Pharmaceuticals Limited 
Address  1389, Trasad Road Dholka, Ahmedabad
Dholka, Ahmedabad
Ahmadabad
GUJARAT
382225
India 
Phone  912714221481  
Fax    
Email  sanjay.p@cadilapharma.co.in  
 
Source of Monetary or Material Support  
Cadila Pharmaceuticals Limited 1389, Trasad Road. Dholka – 382225. Ahmedabad. Gujarat. India. 
 
Primary Sponsor  
Name  Cadila Pharmaceuticals Limited 
Address  1389, Trasad road, Dholka. Ahmedabad - 387810. 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjay Patel  CPPU Cadila Pharmaceutical Limited  1389, Trasad Road Dholka, Ahmedabad
Ahmadabad
GUJARAT 		 09898073861

sanjay.p@cadilapharma.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IBIOME Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Vitamin-D deficient, but otherwise healthy, adult human subjects 
Patients  (1) ICD-10 Condition: E559||Vitamin D deficiency, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cholecalciferol  Aqueous Cholecalciferol 6,00,000 IU/2mL as single-dose, intramuscular Injection 
Comparator Agent  Cholecalciferol  Oil-based Cholecalciferol 600000 IU as single-dose, intramuscular Injection 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Healthy, adult, human subject aged from 18 to 65 years (inclusive both).
2. Subject’s Body Mass Index (BMI) within normal limit of 18.50-30.00 kg/m2 (inclusive both).
3. Healthy Subject with 25-hydroxyvitamin D [25(OH)D] <30ng/mL.
4. Subject not taking any Vitamin D supplementation.
5. Willingness to sign statements of written informed consent form.
6. No contraindications with the study medication with any previous medical or surgical history.
7. Willingness to undergo pre- and post-study physical examinations and laboratory investigations.
8. Normal general physical examination including Normal ECG and vital signs, or abnormalities, which the investigator does not consider a disqualification for participation in the study.
9. Investigations with blood sample of the subjects, shows the presence of values which are within
acceptable range.
10. Those laboratory values outside acceptable range can be considered clinically insignificant as per PI sole discretion.
11. Availability of subject for the entire study period and willingness to adhere to protocol. 
 
ExclusionCriteria 
Details  1. The subject with known drug hypersensitivity or idiosyncratic reaction to Cholecalciferol or any of its inactive ingredient and or with Heparin.
2. Subjects incapable of understanding the informed consent process / procedure.
3. Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study, or limit the ability to comply with protocol requirements.
4. Resting heart rate of >100 beats/min or <60 beats/min on the screening day.
5. History of hypotensive episodes, or systolic blood pressure reading of <100 mm Hg or a diastolic reading of <60 mm Hg at time of general Physical examination.
6. History of hypertension, or systolic blood pressure reading of >140 mm Hg or a diastolic reading >90 mm Hg at time of general Physical examination.
7. The subject has any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
8. Subject who have taken any enzymes modifying drugs within the past four weeks prior to start of clinical period.
9. Subject who have taken any prescribed medications beginning two weeks prior to and OTC medications beginning one week prior to first dosing of study.
10. Investigations with blood samples of the subject shows presence of disease marker of HIV 1 and 2, Hepatitis B & C viruses.
11. Positive test for urinary screen testing of drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturate).
12. Subject found positive for alcohol breath test or urine alcohol test.
13. Investigations with blood sample of the subjects, shows the presence of values which are clinically significantly different from normal reference range.
14. Investigations with urine sample of the subject shows clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC, epithelial cells, glucose and protein (unless the investigator considers the deviation to be irrelevant for the purpose of the study).
15. Subject who participated in any other clinical investigation using experimental drug or had bleed more than 300 mL in the past 90 days.
16. Xanthine-containing food or beverages (tea, coffee, chocolates, soft drinks like cola etc.) within 24 hours prior to the dosing of the study or alcoholic products consumption within 48 hours prior to the dosing of the study.
17. Subjects who have consumed “Grape fruit” or its juice within 72 hours prior to dosing of the study.
18. Subject without adequate venous access in their left or right arm to allow collection of all samples via venous cannula in the study.
19. X-ray chest finding suggesting of any abnormality/ies like cardiomegaly, pneumonia etc.
20. Subject with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and /or renal function, that could interfere with the absorption, metabolism, and /or excretion of the study drugs.
21. Institutionalized volunteers.
22. Females who are falling in menstruation period during study, positive in Urinary Pregnancy Test, lactating, or using any type of hormonal contraceptives. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the pharmacokinetic (PK)/pharmacodynamic (PD) of Cholecalciferol injection
6,00,000 IU/2mL of Cadila Pharmaceuticals Limited, India with marketed Cholecalciferol 600000 IU oil-based injection in Vitamin-D deficient, but otherwise healthy, adult human
subjects under fed condition. 		 Till day 14 post-dosing 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate safety including adverse events and clinical laboratory tests  Till day 14 post-dosing 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/10/2021 
Date of Study Completion (India) 09/02/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is a randomized, open label, two-treatment, single dose, parallel, comparative study to evaluate the PK/PD of Aqueous Cholecalciferol injection 6,00,000 IU/2mL and compare it with oil-based Cholecalciferol 6,00,000 IU in Vitamin-D deficient, but otherwise healthy, adult human subjects under fed condition. 
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