An three-way crossover study of investigational product containing Vitamin D3 in healthy adult, human subjects under fasting conditions

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Powder form of Liposomal Vitamin D3 formulation: Oral Administration 1capsule to be taken only once. capsule containing 1000 IU of conventional Vitamin D3 of Molecules BioLabs Private Limited. Intervention2: Liquid form of Liposomal Vitamin D3 formulation.: Oral Administration 10ml bottle to be taken only once. Every 10ml bottle contain 1000 IU of conventional Vitamin D3 of Molecules BioLabs Private Limited. Control Intervention1: Conventional Vitamin D3 Powder: Oral Administration 1capsule to be taken only once. capsule containing 1000 IU of conventional Vitamin D3 of Molecules BioLabs Private Limited. CONDITION: PRIMARY OUTCOME: To evaluate the oral bioavailability of investigational product‐1000 IU of Vitamin D3 Capsule for Test1 and 1000 IU of Vitamin D3 10 mL Bottle for T2 of Molecules Biolabs Private Limited, and the reference product 1000 IU of conventional Vitamin D3 of Molecules Biolabs Private Limited in healthy, adult, human subjects under fasting conditions. ; Timepoint: at End of study visit. SECONDARY OUTCOME: To monitor the adverse events & to ensure the safety of the subjects.Timepoint: Screening visit to end ofstudy visit. INCLUSION CRITERIA: 1.Normal, healthy, adult, male and female Human participants of age between 18 to 45 years with a Body Mass Inde Xrange between 18.50 to 24.99. 2.Subject agrees avoid Vitamin D3 containing medications and dietary supplements from screening until last visit. 3.Subject agrees to avoid high activity physical exercise 72 hours prior to last visit. 4.Subjects who have no evidence of underlying disease during screening and check in and whose screening is performed within 29 days of check in. 5.Subjects generally healthy as documented at screening considered by the physician or principal or clinical investigator. 6.Healthy as documented by the medical history, physical examination including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems and vital sign assessments. 7.Non smokers or e Xsmokers. E Xsmokers are defined as someon
Epistemonikos ID: b5aa128031ae5195be14003829e3a6a4a42e1e4f
First added on: Oct 08, 2026