None listed
Conditions
Interventions
Intervention1: Berberine 95% (Berberis aristata extract standardized to 95% Berberine): 2 capsules (Dose: 250mg)
Frequency: Period I - single dose
Wash out period - 7 Days
Period 2 - single dose
Intervention2: Berberine 70% (Berberis aristata extract standardized to 70% Berberine): 2 capsules (Dose: 250mg + 250mg)
Frequency: Period I - single dose
Period 2 - single dose
Control Intervention1: Berberine 95% + Turmeric (Berberis aristata extract standardized to 95% Berberine+ Standardized Turmeric extract containing 35% curcuminoids): 2 capsule
Period 2 - single dose
Control Intervention2: Berberine 70% + Turmeric (Berberis aristata extract standardized to 70% Berberine+ Standardized Turmeric extract containing 35% curcuminoids): 2 capsule
Period 2 - single dose
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male and/or non-pregnant, non-lactating female subjects with BMI from 18.5 to 30.0 kg/m2 (both inclusive). 2) Healthy subjects according to medical history, screening assessments (lab and medical examinations). 3) Subjects willing to provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recordings, gynaecological history and present complaints (for female volunteers)]. 2) Subjects having foods containing high concentrations of turmeric or turmeric rich foods within the 14 days prior to drug administration. 3) Subjects with positive serology for HIV and HbsAg. 4) Subjects with usage of berberine supplements. 5) History or evidence of drug dependence or of alcoholism or of moderate alcohol use. 6) Smoker who smokes 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period. 7) Volunteer who has donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or more than 200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater. 8) Intolerance to venipuncture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the oral bioavailability between Formulations A and B and between Formulations C and D by analyzing plasma samples using LC-MS/MS method specific for the determination of berberine.Timepoint: Pre-dose (0.0 hour), 0.25, 0.50, 1.00, 2.00, 4.00 and 8.00 hours (within +2 mins of schedule time) post dose for period 1 and 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of the subjects.Timepoint: Pre-dose (0.0 hour), 0.25, 0.50, 1.00, 2.00, 4.00 and 8.00 hours (within plus 2 mins of scheduled time) post dose for period 1 and 2 | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
Himalaya Wellness Company
Outcome results
None listed