None listed
Conditions
Interventions
Intervention1: ADRENATABâ?¢ (EPINEPHRINE SUBLINGUAL TABLETS): Each Epinephrine sublingual tablets contains 10/20/40/50 mg
Manufactured by: Belcher Pharmaceuticals, USA.
Control Intervention1: Epinephr
Sponsors
Belcher Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: a) Non-smoking, normal, healthy adult human volunteers between 18 to 40 years of age (both inclusive). b) Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in kg / height in meter2. c) Not having any significant disease in medical history or clinically significant abnormal findings during screening, physical examination, laboratory evaluations, 12- lead ECG, TMT, Echocardiography and X-ray chest (P/A view) recordings. d) Able to understand and comply with the study procedures, in the opinion of the principal investigator. e) Able to give voluntary written informed consent for participation in the trial. f) Postmenopausal women with serum FSH levels between 25.8-134.8 mIU/mL. g) In case of female subjects: i. Surgically sterilized at least 6 months prior to study participation Or 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 h) Serum pregnancy test must be negative.
Exclusion criteria
Exclusion criteria: i) Known hypersensitivity or idiosyncratic reaction to Epinephrine and normally used medicines such as anti-histamines, NSAIDs or any of the excipients or related drug. j) 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. k) Ingestion of Monoamine oxidase (MAO) inhibitors from 30 days, prescription medication from 14 days, over-the-counter products including herbal remedies from 7 days prior to the first dosing. In any such case subject selection will be at the discretion of the Principal Investigator. l) Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria. m) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans. n) 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 male and more than 7 standard drinks per week for female (A standard drink is defined as 360 ml of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to dosing period I. o) Smokers, or who have smoked within last six months prior to start of the study. p) Consumption of Epipen within last six months prior to start of the study. q) The presence of clinically significant abnormal laboratory values during screening. r) History or presence of seizure or psychiatric disorders. s) A history of difficulty in donating blood. t) Difficulty in swallowing tablet/capsule. u) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication. v) Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose 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. w) A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies. x) A positive test result for HIV (1 &/ or 2) antibody. y) Consumption of grapefruit or grapefruit products, pomegranate, pineapple, or pomelo from 7 days prior to dosing. z) Consumption of Food containing poppy seeds from 24 hours prior to dosing aa) An unusual diet, for whatever reason (e.g. 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. bb) Nursing mothers (for female subjects).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of single ascending doses of epinephrine sublingual tablet (ADRENATABâ?¢) administered in healthy adult human subjects under fasting study. and To characterize the pharmacokinetics (PK) profile of single ascending doses of epinephrine sublingual tablet (ADRENATABâ?¢) relative to intramuscular (IM) or subcutaneous (SC) epinephrine injection.Timepoint: pre dose -1.000, -0.500, (0.000) and at 0.083, 0.167, 0.250, 0.333, 0.500, 0.667, 1.000, 1.500, 2.000, 3.000, 4.000, 5.000 and 6.000 hours post dose following drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactMr Prashant Modi
Lambda Therapeutic Research Ltd
Outcome results
None listed