A relative Bioavailability study to understand the absorption of 2 different formulations of Vitamin D3 available in Indian Market

Not Applicable

• Registration Number: CTRI/2018/05/013839
• Lead Sponsor: Sanofi Synthelabo India Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: BA/BE
• Study Design: Not specified