None listed
Conditions
Interventions
Intervention1: HRF-4467 Solution 20 mg/mL of
Hetero Labs Limited, India.: Dose: 20 mg/mL
Frequency:
single ascending dose
Duration of treatment: single ascending dose
Control Intervention1: NA: NA
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: a) Non-smoking, normal, healthy adult male human volunteers between 18 to 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India. b) Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in kg per height in meter square. c) Volunteer should be literate d) Not having any significant disease in medical history or clinically significant abnormal findings during screening, physical examination, laboratory evaluations, 12- lead ECG and X-ray chest (P/A view) recordings. e) Able to understand and comply with the study procedures, in the opinion of the principal/Coinvestigator. f) Able to give voluntary written informed consent for participation in the trial.
Exclusion criteria
Exclusion criteria: a) Known hypersensitivity or idiosyncratic reaction to normally used medicines such as antihistamines, NSAIDs or any of the excipients or related drug. 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 a medicine (CYP inducers or inhibitors including herbal medicines) at any time within 14 days before 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) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans. f) A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week (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 products within 48 hours prior to dosing. g) Smokers, or who have smoked within last six months prior to start of the study. h) The presence of clinically significant abnormal laboratory values during screening. i) History or presence of seizure or psychiatric disorders. j) A history of difficulty in donating blood. k) Difficulty in swallowing tablet/capsule. l) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication. m) 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 n) A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies. o) A positive test result for HIV (I & II) antibody. p) Consumption of Grapefruits or its products within 72 hours prior to dosing. q) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of safety, tolerability & pharmacokinetics of HRF-4467 in Healthy Adult Male Human subjects & evaluation of food effect with one cohort in Single Ascending Dose and the safety of the subjects.Timepoint: pre dose (0.000) and at 0.250, 0.500, 1.000, 2.000, 3.000, 4.000, 6.000, 8.000, 10.000, 12.000, 14.000, 16.000, 20.000, 24.000, 36.000, 48.000, 72.000 and 96.000 hours post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha
Lambda Therapeutic Research Ltd
Outcome results
None listed