Single dose, crossover bioavailability study to compare the Formulation A Berberine 95 percent with Formulation B Berberine 95 percent plus Turmeric and Formulation C Berberine 70 percent with Formulation D Berberine 70 percent plus Turmeric in healthy adult human subjects.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Himalaya Wellness Company
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- 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.
Overview
Brief Summary
This is an open label, randomized, comparative, two-period, four-treatment, two-sequence, crossover, balanced, single dose oral bioavailability study to compare the [Formulation A: Berberine 95% with Formulation B: Berberine 95% + Turmeric] and [Formulation C: Berberine 70% with Formulation D: Berberine 70% + Turmeric] in healthy adult, human subjects.
Total expected duration of the clinical part is 09 Days from the day of check-in of first period.
The following PK parameters will be measured: Cmax, AUCt, AUCi, Tmax, Kel, AUC_%Extrap_obs and tHalf.
Study Design
- Study Type
- Ba/be
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male and/or non-pregnant, non-lactating female subjects with BMI from 18.5 to 30.0 kg/m2 (both inclusive).
- •Subjects willing to provide written informed consent to participate in the study.
Exclusion Criteria
- •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)].
- •Subjects having foods containing high concentrations of turmeric or turmeric rich foods within the 14 days prior to drug administration.
- •Subjects with positive serology for HIV and HbsAg. 4) Subjects with usage of berberine supplements.
- •History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
- •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.
- •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.
- •Intolerance to venipuncture.
Outcomes
Primary Outcomes
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.
Time Frame: 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 Outcomes
- To monitor the safety and tolerability of the subjects.(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)
Investigators
Dr Simran Sethi MBBS
Cliantha Research