None listed
Conditions
Interventions
Intervention1: Test Product â?? T1- Thymoquinone Tablet 12.5 mg: Dose- 12.5 mg
Frequency- A single oral dose
Dosage form- Tablet
Route of administration- Oral
Intervention2: Test Product â?? T2- Thymoquinone Tablet 25 mg: Dose- 25 mg
Route of administration- Oral
Intervention3: Test Product â?? T3- Thymoquinone Tablet 50 mg: Dose- 50 mg
Route of administration- Oral
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: a) Non-smoker, Normal, healthy, adult, human volunteers between 18 to 45 years of age (both inclusive). b) Having a Body Mass Index (BMI) between 18.5 to 30.0 (both inclusive). c) Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (P/A view) recordings. d) Able to understand and comply with the study procedures, in the opinion of the investigator. e) Able to give voluntary written informed consent for participation in the study. f) In case of female subjects: i. Surgically sterilized at least 6 months prior to study participation Or ii. If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study. And iii. Serum pregnancy test must be negative.
Exclusion criteria
Exclusion criteria: a) Known hypersensitivity to Thymoquinone or any excipients or any related drug or any substance. b) History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system. c) Ingestion of medicine (prescribed and over the counter (OTC) medication including herbal remedies) at any time within 14 days prior to dosing. In any such case subject selection will be at the discretion of the Principal Investigator. d) Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria. e) A recent history of harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 07 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40 percentage distilled spirits, such as rum, whisky, brandy etc.), or consumption of alcohol or alcoholic product within 48 hours prior to dosing. f) Smokers or who have smoked within last 06 months prior to start of the study. g) The presence of clinically significant abnormal laboratory values during screening. h) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans. i) History or presence of seizure or psychiatric disorders. j) History of difficulty in donating blood. k) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication. l) Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to dosing of study medication. (If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.) m) A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies. n) A positive test result for HIV antibody (1 and / or 2). o) Difficulty in swallowing solids dosage forms like tablets or capsules. p) Positive for pregnancy test (for female subjects). q) Consumption of grapefruit or grapefruit products within 72 hours prior to dosing. r) An unusual diet, for whatever reason (for example, fasting, high potassium or low-sodium), for four weeks prior to receiving the study medicine. In any such case subject selection will be at the discretion of the Principal Investigator. s) Nursing mothers (for female subjects).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess safety, tolerability & characterize the pharmacokinetic profile of the Thymoquinone tablets after single oral dose administration in normal, healthy, adult, human subjects under fasting conditionTimepoint: The venous blood samples will be withdrawn at Pre-dose (0.000 hour) and at 0.333, 0.667, 1.000, 1.500, 2.000, 2.500, 3.000, 4.000, 5.000, 6.000, 7.000, 8.000, 9.000, 10.000, 11.000, 12.000, 15.000, 18.000, 24.000, 48.000, 72.000, 96.000, 144.000 and 192.000 hours post dose administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the subjectsTimepoint: Through out the clinical study for 1 week (i.e. at screening, after check-in, at 01, 03, 06, 11, 24 and 48 hours after administration of IMP, before check-out and at the end of the study). | — |
Countries
India
Contacts
Public ContactMr Prashant Modi
Lambda Therapeutic Research Ltd
Outcome results
None listed