None listed
Conditions
Interventions
Intervention1: Usnoflast (ZYIL1): Dose : 75 mg (50 mg + 25 mg capsule)capsule
Route : Oral
Duration : Single Dose
Control Intervention1: NIL: NIL
Sponsors
Zydus Lifesciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Able to communicate effectively with study personnel. 2) Non-smokers, non-tobacco and non-alcoholic users (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study) 3) Willing to provide written informed consent to participate in the study. 4) All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication.
Exclusion criteria
Exclusion criteria: 1) History of allergic responses to any drugs or any of usnoflast formulation ingredients. 2) Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female volunteers)]. 3) Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system. 4) History or presence of bronchial asthma. 5) Use of any hormone replacement therapy within 3 months prior to the first dose of study medication. 6) Use of any depot injection or implant of any drug within 3 months prior to the first dose of study medication. 7) History or evidence of drug dependence. 8) History of difficulty with donating blood or difficulty in accessibility of veins. 9) A positive hepatitis screen (includes subtypes B & C). 10) A positive test result for HIV antibody. 11) Volunteer who have received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication. 12) History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption. 13) Intolerance to venipuncture 14) Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer s participation in this study. 15) Institutionalized volunteer. 16) Use of any prescribed medications within 14 days prior to the first dose of study medication. 17) Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication. 18) Use of grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication. 19) Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), recreational drugs within 48 hours prior to the first dose of study medication. 20) Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication. 21) SGOT, SGPT and alkaline phosphatase values are 1.1 times higher than the upper limit of normal range during screening. 22) Serum bilirubin values are higher than the upper limit of normal range during screening. 23) Serum creatinine higher than upper limit during screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare and evaluate the oral bioavailability of Usnoflast (ZYIL1) 75mg (Usnoflast (ZYIL1) 50 mg capsule + Usnoflast (ZYIL1) 25 mg capsule) in healthy, adult, human subjects under fasting and fed conditions.Timepoint: Baseline to end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of the subjectsTimepoint: Baseline to end of study | — |
Countries
India
Contacts
Public ContactDr Maulik Doshi
Zydus Lifesciences Ltd
Outcome results
None listed