跳至主要内容
临床试验/NCT05104970
NCT05104970Unknown2 期

Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol

Scotmann Pharmaceuticals0 个研究点目标入组 60 人开始时间: 2022年8月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
60
主要终点
Area Under Curve (AUC)

研究概览

简要总结

The aim of this study is to adapt the gold standard of research and to explore the comparative bioavailability and clinical efficacy of the two most commonly used forms of Cholecalciferol i.e. ampoules and softgel capsules.

详细描述

Deficiency of Vitamin D is highly prevalent in all sectors and regions of Pakistan. Its effects encompass multiple pluripotent physiological impacts on human body, including its classical action on bone health and immune modulation. Health care workers are routinely prescribing supplementations to correct the deficiencies. Different forms of Cholecalciferol are available in the market. It ranges from absorba liquids, drops, tablets, softgels to injectable and oral ampoules. Different delivery systems offer different advantages, challenges and efficacies specific to their specific pharmacokinetics. The aim of this study is to adapt the gold standard of research and to explore the comparative bioavailability and clinical efficacy of the two most commonly used forms of Cholecalciferol i.e. ampoules and softgel capsules.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

double blinded placebo controlled

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

SunnyD STAT softgel capsule

Active Comparator

Cholecalciferol 200000 IU

干预措施: SunnyD STAT softgel capsule (Dietary Supplement)

Placebo SunnyD STAT softgel capsule

Placebo Comparator

Olive oil only

干预措施: Placebo SunnyD STAT softgel capsule (Dietary Supplement)

SunnyD insta ampoule

Active Comparator

Vitamin D3 200000 IU

干预措施: SunnyD insta ampoule (Drug)

Placebo SunnyD insta ampoule

Placebo Comparator

Olive oil only

干预措施: Placebo SunnyD insta ampoule (Drug)

结局指标

主要结局

Area Under Curve (AUC)

时间窗: 70 days

Area Under Curve (AUC) trail follow-up at 0,1,7,28,70. Trapezoidal method for calculations would be used and levels would be reported from lab essay of 25(OH)D

次要结局

  • Serum 25(OH)D level(3 months)

研究者

申办方类型
Industry
责任方
Sponsor

相似试验