None listed
Conditions
Interventions
Intervention1: Seratrodast 80 mg: Orally single dose once in a day
Control Intervention1: Bronica 80 mg (Seratrodast 80 mg): Orally single dose once a day
Sponsors
Zuventus Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 healthy humans within 18 to 45 2 weight at least 45 and BMI in range of18.4 - 25.9 3 normal health as determined by medical history and clionical examination, laboratory and othe test mentioned within normal range 5 willingness to provide writtent informed consent to participate in the study 6 willingness to comply with the requirement of protocol including all the restrictions 7 availability of subject during the entire study period
Exclusion criteria
Exclusion criteria: 1 history of allergy or hypersensitivity to investigational drug 2 abnormilities in vital signs systolic blood pressure 140 mmHg and diostolic blood pressure 90 mmHg or heart rate 100 bpm at screening, pre entry and at pre dose physiccal examination 3 clinically significant cardiovascular, gastrointestinal, liver, renal, pulmonary, hematological, neurological, endocrinal disease 4 History of epilepsy or psychiatric disorder 5 Any illness within 21 days or hospitalized or major illness within three months prior to the first dosing 6 Any other clinical conditions which may be affect absorption, distribution biotransformation or excretion of the study drug 7 Use of any priscribed medication within last two weeks or OTC medical product within last one week preceding first dosing 8 Participated in any other clinical investigation requiring repeted blood sampling/ blood donation program/ have blood lose more than 350 ml from past 90 days 9 History of consumtion of alcohol for more than two years or drink more than two alcohol drinks in a day or consumed alcohol within 48 hrs prior to dosing 10 Smoke more than 10 cigaretts per day or unable to abstain from smoking during study period 11 Consumtion of product containing xanthin and nicotin within 48 hrs before dosing 12 Intake of grapefruits or product containg grape fruits within 72 Hrs prior to receiving the dose of study medication in each period 13 An unusal diet for whatever reson for four weeks prior to receiving study medication 14 Use of any recreational drug or history of drug addiction 15 History of difficulty in vein accessibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seratrodast 80 mgis Bioequivalent to BRONICA 80 mgTimepoint: 17 days | — |
Secondary
| Measure | Time frame |
|---|---|
| No adverse reaction observed during the study periodTimepoint: 19 days | — |
Countries
India
Contacts
Public ContactDr Bhupesh Dewan
Zuventus Healthcare Ltd
Outcome results
None listed