None listed
Conditions
Interventions
Intervention1: Calcirol�® granules: Single dose of Calcirol�® granules will be given by oral route with 240 ml of milk
Control Intervention1: Calcirol�® Soft gelatin capsule: Single dose of Calc
Sponsors
Cadila Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subject who are able to understand and ready to provide written informed consent. Subject must be healthy subject (male/female) human beings within 18-45 years of age (both inclusive). Subject should be having Body Mass Index (BMI) in the range 18.5-24.9 kg/m2 and weighing at least 50 kg. Subject will be declared healthy on the basis of medical history and physical examination, ECG and laboratory tests performed within 21 days prior to the commencement of the study. Subject whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
Exclusion criteria
Exclusion criteria: Subjects who have deficient Vitamin D level. Subject with significant history of hypersensitivity to Study Drug or any ingredients of the formulation or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs. Subject who have suffered any illness or who have been hospitalized within the last 4 weeks preceding the start of the study. Subject who have taken over the counter or prescribed medications, including any enzyme modifying drugs within the last 14 days prior to the study. Subjects who are already taking pain killers or took pain killer within 24 hours of prior to initiation of study. Subject with a history of drug abuse or alcoholism i.e. alcohol consumption more than 2 units per day or 10 units per week (one unit of alcohol equal to 50 ml spirit or 200 ml wine or 500 ml beer) Subject with smoking history of more than 10 Cigarettes per day or Tobacco consumption more than 4 packets per day. Subject who has participated in any other clinical trial requiring repeated blood sampling or a blood donation program or blood loss of more than 450 ml, in the past three months (This 450 mL includes the total blood loss that will occur during the study). Subject with positive Breath Alcohol Analysis before admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the bioavailability and biodistribution pattern of orally administered formulations, transit time and gastrointestinal (GI) clearance of CalcirolÃ?® formulation manufactured by Cadila Pharmaceuticals Limited, Ahmedabad, India in 12 healthy adult human subjects. ââ?¬Â¢ To estimate the vitamin D level in plasma sample of healthy human volunteer on different days.Timepoint: 0, 1, 3, 6, 12, 24 hours,3, 6, 9, 12, 15, 18, 21, 24, 27 and 30 day post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the subjects.Timepoint: 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27 and 30 days after dosing | — |
Countries
India
Contacts
Public ContactDr Ravi Kotadia
Lloyd Institute of Management & Technology
Outcome results
None listed