None listed
Conditions
Interventions
Intervention1: Vitamin D3 1500mcg equivalent to 60,000 IU Vegan capsule (containing VITADEE Green) (Plant Source): 1 Vegan Capsule in fasting conditions with approximately 240 mL of water in sitting
Sponsors
Fermenta Biotech Limited
CLINICA Research Solutions LLP
Eligibility
Inclusion criteria
Inclusion criteria: 1. Must have given voluntary written informed valid consent before any study related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse events. 2. Male and Female participants between greater than equal to 18 and less than equal to 45 years (inclusive) of age (at the day of informed consent signature) 3. Body mass index (BMI) of greater than equal to 18.5 to less than 30 kg per m2 (inclusive), calculated as (weight in kg) divided by (height in m)2 with a total body weight greater than equal to 50kg and less than 100kg at screening. 4. Medically healthy without clinically significant abnormalities including a. Physical examination without any clinically significant findings, in the opinion of the PI or attending physician. b. Systolic blood pressure (BP) in the range of 90 to 140 mm Hg (inclusive) and diastolic BP in the range of 50 to 90 mm Hg (inclusive) after at least 5 minutes rest. c. Pulse rate (PR) in the range of 45 to 100 beats per min (inclusive) after at least 5 minutes rest. d. Respiratory Rate (RR) in the range of 12 to 20 breaths per min (inclusive) after at least 5 minutes rest. e. Body temperature between greater than equal to 95.0 degree Fahrenheit and less than equal to 99.5 degree Fahrenheit (inclusive) f. 12 lead electrocardiogram (ECG) taken after participant has been in supine position for at least 5 minutes, with a QT interval corrected using the Fridericia method (QTcF) less than equal to 450 msec for males and less than equal to 470 msec for females and no clinically significant abnormalities, in the opinion of the PI. g. Adequate bone marrow function as defined by absolute neutrophil count, platelet count and hemoglobin levels within normal ranges (per local laboratory standards). h. Adequate liver function as defined by Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and bilirubin less than equal to 1.5 times upper limit of normal (ULN) Serum albumin test within normal range (per local laboratory reference range) i. Adequate renal function as defined by Serum Creatinine less than equal to 1.5 times ULN j. No other clinically significant findings in serum chemistry, hematology and urine analysis examination, in the opinion of the PI. 5. Participants with a baseline 25 hydroxy vitamin D (25 OH Vitamin D Total) level between 20 30 ng per ml (inclusive). 6. Non alcohol drinkers (lifelong teetotallers) 7. Non smoker who has never used tobacco or nicotine containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch nicotine gum, e cigarettes). 8. Participant must agree to abstain from xanthine containing products (i.e. coffee, tea, cola, energy drinks, chocolate, cola drinks etc.) from 48 hrs prior to the study drug administration until the end of the study. 9. Participants must not consume and agree to continue to abstain from St Johns Wort, vitamins and herbal remedies from 2 weeks prior to the first study drug administration until the end of the study. 10. Participants must not consume and agree to continue to abstain from beverages or food containing grapefruit, grapefruit hybrids, pomelos, pomegranate, star fruit, seville oranges, poppy seeds from 2 weeks prior to the study drug
Exclusion criteria
Exclusion criteria: 1. Pregnant and Lactating females, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test. 2. Known history of hypersensitivity or idiosyncratic reaction to cholecalciferol, ergocalciferol or vitamin D metabolites like e.g. calcitriol, calcifediol, alfacalcidol, calcipotriol, or related drugs or any substance. 3. Participants with hypercalcemia or hypercalciuria, nephrolithiasis or nephrocalcinosis, hypervitaminosis D. 4. Participants with history of relevant orthostatic hypotension, fainting spells or blackouts. 5. Reports any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, urologic, gastrointestinal, hepatic, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the PI or attending Physician. 6. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the participant in case of participation in the study. Note The Investigator should be guided by evidence of any of the following a. History of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding. b. History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, cholecystectomy or bowel resection. c. History of, or clinical evidence of, pancreatic injury or pancreatitis. d. Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests such as ALT, AST, GGT, ALP, or serum bilirubin. e. Malabsorption syndrome. f. History of impaired renal function or elevated creatinine values indicating impaired renal function. g. Evidence of urinary tract obstruction or difficulty in voiding at screening. 7. History of atopic allergy (asthma, urticaria, and eczematous dermatitis). 8. History of cancer including lymphoma, leukemia, and skin cancer. 9. Have had major surgery within 30 days prior to screening or will have a surgery planned between screening and the end of the study visit. 10. Medical, psychiatric, cognitive or other conditions that may have compromised the participants ability to understand the participant information, give informed consent, comply with the study protocol or complete the study. 11. Use of prescription or over the counter products known to interact with vitamin D such as aspirin and Non-Steroidal Anti-Inflammatory Drug (NSAIDs), aluminium, iron, and proton pump inhibitors 2 weeks prior to study drug administration or repeated use of drugs within last 2 weeks. 12. An unusual diet, for whatever reason (e.g. low sodium), for 4 weeks prior to first study drug administration. 13. Participants who have received active vitamin D3 compounds or a high dose of vitamin D3 (greater than 5000IU) within 4 weeks before study drug administration. 14. Reports a history of clinically significant food allergies. 15. Reports difficulty fasting or consuming standardized meals. 16. Reports difficulty in swallowing oral solid dosage form like capsule. 17. Receipt of an intervention or participation in a drug research study within a period of 90 days prior to the study drug administration. [If intervention is
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of 25(OH)D3 in plasma (baseline corrected and baseline uncorrected) and corresponding noncompartmental derived Pharmacokinetics (PK) parameters (Area under the plasma concentration time curve (AUC) from time of administration to last observed plasma concentration (AUC0 to t), maximum observed plasma concentration (Cmax), AUC Test (T) vrs Reference (R) ratios).Timepoint: In-house pharmacokinetic sampling should occur at -24.00; -16.00; -08.00, 00.00 hours pre-dose and post dose 02.00, 04.00; 06.00; 08.00; 09.00; 10.00; 10.50; 11.00; 11.50; 12.00; 12.50; 13.00; 13.50; 14.00; 15.00; 16.00; 18.00; 20.00; 24.00; 30.00; 36.00; 48.00; 72.00; and ambulatory visit samples at 96.00; 120.00; 144.00 hours after drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary PK parameters of 25(OH)D3 Time to reach (T max), AUC from time of administration to infinity (AUC 0 to infinity), terminal halflife (t1 by 2), AUC Extrap, AUCratio and apparent firstorder terminal rate constant (Kel).Timepoint: In-house pharmacokinetic sampling should occur at -24.00; -16.00; -08.00, 00.00 hours pre-dose and post dose 02.00, 04.00; 06.00; 08.00; 09.00; 10.00; 10.50; 11.00; 11.50; 12.00; 12.50; 13.00; 13.50; 14.00; 15.00; 16.00; 18.00; 20.00; 24.00; 30.00; 36.00; 48.00; 72.00; and ambulatory visit samples at 96.00; 120.00; 144.00 hours after drug administration.;Incidence, nature and severity of treatment-emergent adverse events (TEAEs).Timepoint: From time of study drug administration to end of study.;Treatment emergent serious adverse events (treatment-emergent SAEs).Timepoint: From time of study drug administration to end of study.;Changes in clinical laboratory parameters, vital signs, physical examinations, 12 Lead Electrocardiogram (ECG).Timepoint: Baseline to end of study. | — |
Countries
India
Contacts
Public ContactPravinkumar Pal
CLINICA Research Solutions LLP
Outcome results
None listed