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Comparative Pharmacokinetics of Cholecalciferol Oral Delivery Systems
NCT05104970Phase 2
Key facts
- Status
- Unknown
- Start
- Aug 2022
- Primary completion
- Jan 2023
- Sponsor
- Scotmann Pharmaceuticals
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Drugs
- vitamin d
- Conditions
- Vitamin D deficiency (VDD)
01
Overview
Phase 2, randomised, double-blind trial of vitamin d in Vitamin D deficiency (VDD) (4 arms), sponsored by Scotmann Pharmaceuticals. Primary endpoint: Area Under Curve at 70 days. Status: unknown.
02
Design
4 arms- Study design
- RandomizedDouble-blind
SunnyD STAT softgel
Cholecalciferol 200,000 IU Softgel
Placebo softgel
Olive oil Softgel
SunnyD insta ampoule
Cholecalciferol 200,000 IU Ampoule
Placebo ampoule
Olive oil Ampoule
03
Endpoints
Primary
Area Under Curve
Secondary
Serum 25-Hydroxyvitamin D Level
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