None listed
Conditions
Interventions
Intervention1: BAK-010 (Boswellia serrata Extract): Single dose 4 x 490 mg Soft Gelatin Capsule, ROA - Oral
Control Intervention1: BSX-65 (Boswellia serrata extract): Single dose 6 x 500 mg Hard Gelat
Sponsors
Arjuna Natural Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subject must meet all of the following criteria in order to be included in the study. Subject from the pool of healthy volunteers who were screened within 21 days prior to the first dosing day. Subject who are able and ready to provide written informed consent. Subject must be healthy male within 18-45 years of age (both inclusive). Subjects should be having Body Mass Index (BMI) in the range 18.5-30 kg/m2 and weighing at least 50 kg. Subject must be of normal health as determined by medical history and physical examination, ECG, Chest X-Ray and laboratory tests performed within 21 days prior to the commencement of the study.
Exclusion criteria
Exclusion criteria: Subject must have none of the following criteria in order to be included in the study. History of allergic responses to Boswellia serrata extract or related products containing Boswellia Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination, laboratory evaluations, ECG, chest X-ray recording A depot injection or implant of any drug within 3 months prior to administration of study medication. Subjects who have taken any investigational drug within 4 months and any drugs within 7 days prior to the initial dose of study drug. Subject have donated blood (1 unit or 450 mL) within 90 days prior to the initial dose of the study drug or have blood loss, excluding volume drawn at screening for this study, (200 mL within 90 days) prior to initial dose of study drug, whichever is greater. Subject with presence or history of significant gastrointestinal, liver or kidney disease, or any conditions (like history of difficulty in swallowing) known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Co-Investigator, could contraindicate the volunteerâ??s participation in this study. Subjects with active peptic ulceration or a history of peptic ulceration. Subject with resting hypotension (BP 139/89) Subject with Pulse rate below 50/ min. and above 99/min. Subjects with a history of clinically significant, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. Subjects with a history of Myocardial Infarction, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Renal Impairment, Epilepsy and Intracranial hemorrhage. Subjects with a history of known food allergy Subjects who have suffered any illness or who have been hospitalized within the last 4 weeks preceding the start of the study. Subjects who have taken over the counter or prescribed medications, herbal supplements containing Boswellia, including any enzyme modifying drugs within the last 14 days prior to the study. Subject who have a History of drug abuse or alcoholism i.e. alcohol consumption greater than 2 units per day or 10 units per week (one unit of alcohol equals 50mL spirit or 200mL wine or 500mL beer) Smoker or have stopped smoking less than 1 yr. Subject with clinically significant abnormal lab values or abnormal ECG and Chest X-Ray. Subject who has difficulty with donating blood. Intolerance to venipuncture. Subject with positive Breath Alcohol Analysis or Urine Drug Screen (UDS) before admission.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the oral bioavailability of bioactives of two extracts of Boswellia serrata in 16 healthy adult human subjects under fasting conditions.Timepoint: 0 (predose), 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 16 and 24 hours post dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the subjectsTimepoint: 0 (predose),1, 2, 4, 6, 8, 12, 24 hours post-dose. | — |
Countries
India
Contacts
Public ContactDr Binu T Kuruvilla
Arjuna Natural Limited
Outcome results
None listed