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

Not yet recruiting

Conditions: Vitamin D deficiency

Registration Number: CTRI/2018/05/013839

Lead Sponsor: Sanofi Synthelabo India Private Limited

Brief Summary: Thisstudy is a Randomized, Open Label, Balanced, Two Treatment, Two period, TwoSequence, Single Dose, Crossover, Relative Bioavailability Study to compare theabsorption of Vitamin D from 2 different formulations available in the IndianMarket.

The Primary objective is to compare the **AUC0-120** and the secondaryobjective is to monitor the safety and tolerability of a single oral dose ofinvestigational products (IPs) and to compare the **Cmax and Tmax** of Test Product: Depura Oral Solution (T) with one other ReferenceProduct Uprise D3 Soft gelatin capsules (R) in Normal, Healthy, Adult, Male AndFemale, Human Subjects under Fasting Condition.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 26

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 Î² Beta hCG Human Chorionic Gonadotropin test 15 Pregnant defined as positive Î² 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

Primary Outcome Measures

Name	Time	Method
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	5 minutes prior to dosing and 1,2,4,6,8,10,15,24,36,48,72,96 and 120 hours post dosing
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
Adult	5 minutes prior to dosing and 1,2,4,6,8,10,15,24,36,48,72,96 and 120 hours post dosing
Male And Female	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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): Accutest Research Laboratories India Pvt Ltd
🇮🇳
Mumbai, MAHARASHTRA, India
Accutest Research Laboratories India Pvt Ltd
🇮🇳Mumbai, MAHARASHTRA, India
Dr Santosh Kale
Principal investigator
912227780718
santosh.kale@accutestglobal.com