NCT05104970

Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Scotmann Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Vitamin D Deficiency

Interventions

Type	Name	Description
DRUG	SunnyD insta ampoule	Cholecalciferol 200000 IU insta ampoule
DIETARY_SUPPLEMENT	SunnyD STAT softgel capsule	Cholecalciferol 200000 IU softgel capsule
DRUG	Placebo SunnyD insta ampoule	Olive oil
DIETARY_SUPPLEMENT	Placebo SunnyD STAT softgel capsule	Olive oil

Timeline

• Start date: 2022-08-09
• Primary completion: 2023-01-09
• Completion: 2023-02-10
• First posted: 2021-11-03
• Last updated: 2022-05-26