An open label, balanced, randomized, two treatment, two period, two sequence, cross over, comparative bioavailability study of a single dose of commercially available 6 gm Curcumin hard gelatin capsules (each capsule contains 500 mg of Curcumin 95%) and 6 gm Curcumin soft gelatin capsules (each capsule contains 750 mg of Curcumin 95%) of Amsar Private Limited, in healthy human adult male subjects under fed condition.
- Registration Number
- CTRI/2009/091/000327
- Lead Sponsor
- Amsar Private limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
The subjects will be included based on the following criteria:
1)Subject who are able and ready to provide written informed consent independently.
2)Subjects must be healthy human beings within 18-45 years of age (both inclusive).
3)Subjects should be of ideal body weight in relation to height according to Life Insurance Corporation of India? height-weight chart for non-medical cases.
4)Subjects must be of normal health as determined by medical history and physical examination, ECG and laboratory tests performed within 21 days prior to the commencement of the study.
5)Subjects whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
6)Alcohol Breath analysis and Urine drug of Abuse test will be done at admission of both period. Subjects with negative results for both the tests will be only admitted in the study.
The subjects will be excluded based on the following criteria:
1)Subjects incapable of understanding the informed consent process or not ready to sign informed consent.
2)Subjects with Hypersensitivity and/or intolerance and/or contraindication to curcumin or any ingredients of the formulation or related group of drugs
3)Subjects with active or a history of peptic ulceration.
4)Subject with resting hypotension (BP <90 /60) or hypertension (BP ≥140 /90).
5)Subject with Pulse rate below 60 / min. and above 100 /min
6)Subjects with or prior history of clinically significant, Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
7)Subjects with a history of known food allergy.
8)Subjects who have suffered any illness or who have been hospitalized within the last 4 weeks preceding the start of the study.
9)Subjects who have taken over the counter or prescribed medications, including any enzyme modifying drugs within the last 14 days prior to the study.
10)Subject who have a History of drug abuse or alcoholism i.e. alcohol consumption > 2 units / day or 10 units / week (one unit of alcohol = 50 ml spirit or 200 ml wine or 500ml beer).
11)Subject who have Smoking History of > 10 Cigarettes / day or Tobacco consumption > 4 packets / day
12)Subjects who participated in any other clinical trial requiring repeated blood sampling or a blood donation program or blood volume of more than 550 mL, in the past three months ( approx. 90 days ) ( This 550 mL includes the total blood volume that will occur during the study).
13)Subject with clinically significant abnormal lab values / abnormal ECG or chest X-ray.
14)Subject who has difficulty with donating blood.
15)Alcohol Breath analysis and Urine drug of Abuse test will be done at admission of both period. If any subject will be found positive for any of these tests, subject will be dropped out of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the comparative bioavailability of a single dose of commercially available 6 gm Curcumin hard gelatin capsules (each capsule contains 500 mg of Curcumin 95%) and 6 gm Curcumin soft gelatin capsules (each capsule contains 750 mg of Curcumin 95%) of Amsar Private Limited, in healthy human adult male subjects under fed condition.Timepoint: Predose,0.25,0.50,0.75,1.00,1.25,1.50,1.75,2.00,3.00,4.00,6.00,8.00,12.00,24.00<br>
- Secondary Outcome Measures
Name Time Method To assess the safety of the formulations on the basis of clinical and laboratory examinations at the beginning and at the end of the trial and registration of adverse events and/or adverse drug reactionsTimepoint: NI