To check blood concentration and distribution of Calcirol�® granules and soft gelatin capsule of Marketed products of Cadila Pharmaceuticals Limited in twelve healthy persons.
- Registration Number
- CTRI/2022/01/039111
- Lead Sponsor
- Cadila Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
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.
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
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the bioavailability and biodistribution pattern of orally administered formulations, transit time and gastrointestinal (GI) clearance of Calcirol�® formulation manufactured by Cadila Pharmaceuticals Limited, Ahmedabad, India in 12 healthy adult human subjects. <br/ ><br>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 Outcome Measures
Name Time Method To monitor the safety of the subjects.Timepoint: 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27 and 30 days after dosing