None listed
Conditions
Interventions
Intervention1: Liposomal berberine: Dose:1000mg Dosage form: Capsules frequency: period 1:Single dose Wash out period:5 Days Period 2:Single dose
Intervention2: Test Arm 2: Non liposomal Berberine: Do
Sponsors
SPECNOVA LLC
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects must be healthy human male and female (non-pregnant) subjects. 2.Age should be between 18-45 years of age (both inclusive), weighing at least 50 kg. 3.Subject who are ready to provide written informed consent and should be willing to be available throughout the study duration and should follow the guidelines mentioned in the protocol. 4.Subjects with no evidence of underlying disease during the pre-study screening. They must be healthy as determined by medical history and physical examination, ECG, Chest X-ray (PA View) and laboratory tests performed within 7 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.
Exclusion criteria
Exclusion criteria: 1. Subjects who are allergic to Berberine products or any food or other drugs. 2. Subjects who had taken drugs to reduce fat or statins or vitamin supplements (including vitamin E) during the last month 3. Subject with resting hypotension (BP lessthan90 /60) or hypertension (BP greeter than 140 /90) and pulse rate below 50/min and more than 100/min. 4. Subject with or a prior history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, musculoskeletal or psychiatric disease or who has been hospitalized or underwent surgery within the last 4 weeks prior to in-housing. 5. Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Asthma, Renal Impairment, Epilepsy and Intracranial hemorrhage. 6. Subjects who have taken over the counter or prescribed medications including any enzyme modifying drugs within the last 14 days prior to the study. 7. Subject who has a history of alcoholism, drug abuse or Smoking. 8. Subjects who are hypersensitive to Heparin 9. Subjects who participated in any other clinical study in the past three months. 10. Subject with clinically significant abnormal lab values/ abnormal ECG / abnormal Chest X ray (PA View). 11. Subject who has difficulty with donating blood. 12. Subject with history of difficulty in swallowing. 13. Subject who has unsuitable veins for repeated venipuncture.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the bioavailability of liposomal berberine and berberine formulations in plasma by LC-MS/HPLC. Timepoint: 0min, 20min, 40min, 60min, 90min, 120min, 240min, 360min, 480min, 720min and 24 hrs for period 1and 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the changes in biomarkers viz., plasma berberine, Glucose and Insulin. 2. To monitor the safety and tolerability of a single dose of liposomal berberine and berberine formulations by reviewing adverse events.Timepoint: Day 0 to End of the study | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt Ltd
Outcome results
None listed