None listed
Conditions
Interventions
Intervention1: Ginactiv (Ginger) Capsules 300 mg 100 mg Ginactiv and 200 mg HPMC: A single dose of Test Product will be administered orally with 250±2 mL of water in sitting position at ambient tempe
Sponsors
Aurea Biolabs Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Volunteers who accept for participating in this study must: ï?? Is and will be available to participate for the entire study period and have willingness to adhere to Protocol requirements as evidenced by the written ICF duly signed by the volunteer. ï?? Is a healthy human subject in the age group between 18 to 45 years (both inclusive) and BMI must be within the range of 18.50 â?? 24.90 Kg/m2 (both inclusive) with minimum body weight 50kg. ï?? Has no evidence of any underlying disease during screening, medical history and whose physical examination is performed within 28 days prior to drug administration of Period I. ï?? Has screening laboratory values within normal limits or considered by the Investigator to be of no clinical significance. ï?? Agreeing not to consume food, drink and condiment containing ginger during the all duration of the study. ï?? Does not have alcohol dependence, alcohol abuse or drug abuse (Amphetamines, Cocaine, Tetra Hydro Cannabinoids, Benzodiazepines, Barbiturates and Opioids) within the past one year. ï?? Agrees to abstain from consuming xanthine-containing food products or beverages (chocolates, tea, coffee or cola drinks), tobacco containing products (cigarettes, pan, ghutka etc.,) and alcohol containing beverages from 48.00 prior to dosing of period I and during the entire study. ï?? Agree to abstain from grapefruit and grapefruit containing products from 07 days prior to dosing of period I and during the entire study. ï?? Tested negative for pregnancy â?? Serum and/ or urine β-hCG (applicable for female volunteers). ï?? Is a female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the Investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence. ï?? Is declared eligible to participate in the study by the investigator(s).
Exclusion criteria
Exclusion criteria: The volunteer will not be enrolled into the study if: ï?? Has allergy or significant history of hypersensitivity or idiosyncratic reaction to Ginger or any other excipients in the particular product. ï?? Is currently suffering from or has clinically significant history of Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrinal, immunologic, dermatologic, neurological or psychiatric disease. ï?? Has systolic blood pressure 140 mmHg (exclude limits) or diastolic blood pressure 90 mmHg (exclude limits) and pulse rate 100 beats per minute (exclude limits). ï?? Suffering from Irritable Bowel Syndrome (IBS) diagnosed by a medical doctor and treated with chronic medication. ï?? Under treatment and/or dietary supplement and/or "health food" which could significantly affect study parameters during the study according to the investigator. ï?? Has difficulty in swallowing solution or coming for follows ups. ï?? Had suffered from a clinically significant illness within 4 weeks prior to commencement of the study. ï?? Tested positive to alcohol breathe analysis, urine drug abuse screening test, HIV I and II antibodies, RPR for T. pallidum and HBsAg. ï?? Is currently suffering from or has a history of gastric and/ or duodenal ulcer, Asthma, urticaria or other allergic type reactions after taking aspirin. ï?? Is currently using or has a history of using enzyme modifying drugs (like phenytoin, carbamazepine, barbiturates, griseofulvin etc.) in the past 28 days prior to period I dosing. ï?? Has an abnormal 12-lead ECG and Chest X- ray (PA view). ï?? Has participated in other clinical trials and or blood donation or blood lost more than 300 mL within last 90 days for male and 120 days for female of period I dosing. ï?? Is currently breast feeding or pregnant (applicable for female volunteers). ï?? Volunteers having signs and symptoms of COVID-19 or history of travel/ contact with any COVID-19 positive patient/isolation/quarantine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the rate and extent of absorption of Ginactiv (Ginger) Capsules 300 mg with Ginger Extract powder capsules 300 mg and Placebo capsules 300 mg in normal healthy adult human subjects under fasting conditionsTimepoint: 10 days from Period I check-in to Period III check-out. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of Ginactiv (Ginger) Capsules 300 mg after oral administration in normal healthy adult human subjects under fasting conditions.Timepoint: 10 days from Period I check-in to Period III check-out. | — |
Countries
India
Contacts
Public ContactDivya chandradhara
Bio Agile therapeutics Pvt Ltd
Outcome results
None listed