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临床试验/CTRI/2025/10/096653
CTRI/2025/10/096653招募中不适用

A randomized, double-blind, single-center, single-dose, single-period, two-treatment, parallel oral bioequivalence study of Vitamin D3 1500mcg equivalent to 60,000 IU Vegan capsule (containing VITADEE™ Green) in comparison with Vitamin D3 1500mcg equivalent to 60,000 IU softgel capsule (animal source) in healthy adult human participants under fasting conditions.

Fermenta Biotech Limited1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年3月14日最近更新:
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试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
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).
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Vitamin D3 (Cholecalciferol) is widely used in the management and prevention of Vitamin D deficiency, with 60,000 IU soft gelatin capsules forming the mainstay of high-dose supplementation protocols in India. Traditionally, this active ingredient is derived from animal sources, cholesterol obtained from sheep wool grease. With increasing demand for vegan and plant-based alternatives, formulations containing Soyabean-derived cholecalciferol have been developed.

 To ensure therapeutic/ clinical equivalence and facilitate regulatory approval, it is essential to establish bioequivalence (BE) between the plant-based formulation and the reference animal-based formulation.

 This study is being conducted to demonstrate bioequivalence and characterize the pharmacokinetic profile of the test formulations with respect to the reference formulation in normal healthy adult human participants under fasting conditions.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Double

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)（—）
性别
All

入选标准

  • •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.
  • •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)
  • •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.
  • •Medically healthy without clinically significant abnormalities including a.
  • •Physical examination without any clinically significant findings, in the opinion of the PI or attending physician.
  • •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.
  • •Pulse rate (PR) in the range of 45 to 100 beats per min (inclusive) after at least 5 minutes rest.
  • •Respiratory Rate (RR) in the range of 12 to 20 breaths per min (inclusive) after at least 5 minutes rest.
  • •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.
  • •Adequate bone marrow function as defined by absolute neutrophil count, platelet count and hemoglobin levels within normal ranges (per local laboratory standards).
  • •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.
  • •Participants with a baseline 25 hydroxy vitamin D (25 OH Vitamin D Total) level between 20 30 ng per ml (inclusive).
  • •Non alcohol drinkers (lifelong teetotallers)
  • •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).
  • •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.
  • •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.
  • •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 administration until the end of the study.
  • •Participants ready to avoid most dairy products, vitamin D3 fortified foods, and foods known to be high in vitamin D3 from 2 weeks prior to the study drug administration until the end of the study.
  • •Participants agree to wear sunblock of at least SPF 45 during the study and not to have excessive sun exposure (no more than 1 hr without sunblock) during the study period.
  • •Participants ready to avoid prolonged, direct sunlight for at least 2 weeks prior to the study drug administration until the end of the study.
  • •Participants ready to avoid sun baths, solarium, or sauna for at least 2 weeks prior to the study drug administration until the end of the study.
  • •Female participants must a.
  • •Be of non childbearing potential i.e. surgically sterilized (for example hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the screening visit) or postmenopausal (where postmenopausal is defined 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels greater than 40 mIU per mL and serum estradiol less than 20 pg per mL [except if treated with hormone replacement therapy (HRT)] b.
  • •If of childbearing potential: Must have negative serum pregnancy test at screening visit and a negative urine pregnancy test at Check in.
  • •Must not be breastfeeding, lactating or planning pregnancy during the study period.
  • •Must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the dose of assigned treatment.
  • •Must agree not to donate ova for at least 30 days after the dose of study drug.
  • •Male participants with a female partner of childbearing potential must use an effective method of birth control or practice abstinence for the entire study duration, and for up to 30 days following the dose of the study treatment.
  • •Must agree not to donate sperm for at least 30 days after the dose of study drug.
  • •Note: The following birth control is recommended condom for the male participant and an intrauterine device with spermicide or oral or implanted hormonal contraception for the female partner.
  • •Motivated participants with absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to participate in the study or the ability to understand and observe the instructs of the investigator or designee.
  • •Able to communicate well with the investigator and study team and comply with the requirements of the study.

排除标准

  • •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.
  • •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.
  • •Participants with hypercalcemia or hypercalciuria, nephrolithiasis or nephrocalcinosis, hypervitaminosis D.
  • •Participants with history of relevant orthostatic hypotension, fainting spells or blackouts.
  • •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.
  • •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.
  • •History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, cholecystectomy or bowel resection.
  • •History of, or clinical evidence of, pancreatic injury or pancreatitis.
  • •Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests such as ALT, AST, GGT, ALP, or serum bilirubin.
  • •Malabsorption syndrome.
  • •History of impaired renal function or elevated creatinine values indicating impaired renal function.
  • •Evidence of urinary tract obstruction or difficulty in voiding at screening.
  • •History of cancer including lymphoma, leukemia, and skin cancer.
  • •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.
  • •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.
  • •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.
  • •An unusual diet, for whatever reason (e.g. low sodium), for 4 weeks prior to first study drug administration.
  • •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.
  • •Reports a history of clinically significant food allergies.
  • •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 received within 90 days where there is no blood loss except safety lab testing, participant can be included considering 10 half-lives duration of intervention received.]
  • •Reports donating blood (1 unit or 350 mL) within a period of 90 days prior to the study drug administration.
  • •Presence of any clinically significant results from laboratory tests, vital signs assessments, chest X-ray and ECG during screening, as judged by the PI or attending Physician.
  • •A positive hepatitis screen including hepatitis B surface antigen and, or HCV antibodies.
  • •A positive test result for HIV antibody (1 and, or 2).
  • •Demonstrate a positive urine screening for drugs of abuse (Cannabinoids-CANNAB, Amphetamine-AMP, Barbiturates-BAR, Cocaine-COC, Benzodiazepines-BZD and Morphine-MOR) on the day of check-in.
  • •Demonstrate a positive alcohol breath test on the day of check-in.
  • •Demonstrates, in the opinion of study staff, veins unsuitable for repeated venipuncture (e.g. veins difficult to locate, access, or puncture; veins with a tendency to rupture during or after puncture).
  • •The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
  • •Performance of unaccustomed strenuous physical exercise (body building, high performance sports) from 2 weeks prior to study drug administration and throughout the entire study.
  • •Any condition not identified in the protocol that in the opinion of the PI would confound the evaluation and interpretation of the study data or may put the participant at risk.

结局指标

主要结局

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).

时间窗: 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

次要结局

  • 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).(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).(From time of study drug administration to end of study.)
  • Treatment emergent serious adverse events (treatment-emergent SAEs).(From time of study drug administration to end of study.)
  • Changes in clinical laboratory parameters, vital signs, physical examinations, 12 Lead Electrocardiogram (ECG).(Baseline to end of study.)

研究者

发起方
Fermenta Biotech Limited
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Sachin Pawar

CLINICA Research Solutions LLP

研究点 (1)

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