CTRI/2021/10/037407已完成不适用
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 CadilaPharmaceuticals Limited, India with marketed Cholecalciferol 600000 IU oil-based injection in Vitamin-D deficient, but otherwise healthy, adult human subjects under fed condition.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To evaluate the pharmacokinetic (PK)/pharmacodynamic (PD) of Cholecalciferol injection
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy, adult, human subject aged from 18 to 65 years (inclusive both).
- •Subject’s Body Mass Index (BMI) within normal limit of 18.50-30.00 kg/m2 (inclusive both).
- •Healthy Subject with 25-hydroxyvitamin D [25(OH)D] <30ng/mL.
- •Subject not taking any Vitamin D supplementation.
- •Willingness to sign statements of written informed consent form.
- •No contraindications with the study medication with any previous medical or surgical history.
- •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.
- •Investigations with blood sample of the subjects, shows the presence of values which are within acceptable range.
- •Those laboratory values outside acceptable range can be considered clinically insignificant as per PI sole discretion.
- •Availability of subject for the entire study period and willingness to adhere to protocol.
排除标准
- •The subject with known drug hypersensitivity or idiosyncratic reaction to Cholecalciferol or any of its inactive ingredient and or with Heparin.
- •Subjects incapable of understanding the informed consent process / procedure.
- •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.
- •Resting heart rate of >100 beats/min or <60 beats/min on the screening day.
- •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.
- •The subject has any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
- •Subject who have taken any enzymes modifying drugs within the past four weeks prior to start of clinical period.
- •Subject who have taken any prescribed medications beginning two weeks prior to and OTC medications beginning one week prior to first dosing of study.
- •Investigations with blood samples of the subject shows presence of disease marker of HIV 1 and 2, Hepatitis B & C viruses.
- •Positive test for urinary screen testing of drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturate).
- •Subject found positive for alcohol breath test or urine alcohol test.
- •Investigations with blood sample of the subjects, shows the presence of values which are clinically significantly different from normal reference range.
- •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).
- •Subject who participated in any other clinical investigation using experimental drug or had bleed more than 300 mL in the past 90 days.
- •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.
- •Subjects who have consumed “Grape fruit†or its juice within 72 hours prior to dosing of the study.
- •Subject without adequate venous access in their left or right arm to allow collection of all samples via venous cannula in the study.
- •X-ray chest finding suggesting of any abnormality/ies like cardiomegaly, pneumonia etc.
- •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.
- •Institutionalized volunteers.
- •Females who are falling in menstruation period during study, positive in Urinary Pregnancy Test, lactating, or using any type of hormonal contraceptives.
结局指标
主要结局
To evaluate the pharmacokinetic (PK)/pharmacodynamic (PD) of Cholecalciferol injection
时间窗: Till day 14 post-dosing
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
时间窗: Till day 14 post-dosing
subjects under fed condition.
时间窗: Till day 14 post-dosing
次要结局
- To evaluate safety including adverse events and clinical laboratory tests(Till day 14 post-dosing)
研究者
研究点 (1)
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