None listed
Conditions
Interventions
Intervention1: ZY-19489: Dose:900 mg tablet
Route:Oral
Duration:-Single dose
Frequency: Once
Intervention2: ZY-19489: Dose:300 mg x 3 capsule
Route:Oral Duration:-Single dose Frequency: Once
Control
Sponsors
Zydus Lifesciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and/or non-pregnant, non-lactating female subjects aged between 18 and 50 years (Both inclusive). 2.Male subjects and/or female subjects of childbearing potential must agree to use effective contraception till study completion. 3.Body weight greater than 50 kg and BMI within the range greater than equal to 18.5 - less than equal to 29.9 kg/m2 (Both inclusive). 4.Capable of giving written informed consent, which includes compliance with the study procedures, restrictions, and requirements listed in the protocol. 5.Ability to communicate effectively with study personnel. 6.Participants who, in the opinion of the Investigator, are healthy as determined by their pre study medical history, clinical examination, 12-lead ECG and clinical laboratory tests within the institutional normal range or judged as not clinically significant by the Investigator.
Exclusion criteria
Exclusion criteria: 1.History of alcohol consumption or tobacco use or drug abuse within the past 1 year of enrollment or subject’s currently taking alcohol and/or tobacco products. 2.Difficulty with donating blood or Inability to be venipuncture or tolerate venous puncture 3.Systolic blood pressure more than 140 mmHg or less than 100 mmHg and diastolic blood pressure more than 90 mmHg or less than 60 mmHg. 4.Pulse rate less than 55/minute or more than 100/minute. 5.Any clinically significant laboratory or ECG findings during screening as per discretion of investigator. 6.Surgery within last 3 months or planned major surgery within next 3 months from the date of screening. 7.Any major illness during last 3 months as per Investigator discretion. 8.Volunteers who have participated in any drug research study within past 3 months. 9.Volunteers who have donated one unit (350 ml) of blood in the past 3 months. 10.History or presence of diagnosed or treated food or known drug allergies or history of anaphylaxis or other severe allergic reactions. 11.Subjects not willing to use contraceptives till completion of the study. 12.Subjects who are found positive urine alcohol test or urine test for drug of abuse at the time of check in. 13.Female subjects with history of pregnancy or lactation in the past 3 months 14.Female subjects with history of less than 1 year of menopause and not using adequate anti-fertility measures. 15.Difficulty in swallowing of tablet or capsule. 16.Presence or suspicion of active viral, bacterial, fungal, or parasitic infection within 14 days before administration of the first dose of study drug. 17.Participants who have recent illness (eg, fever) within 14 days of enrollment. 18.Consumption of beverages or food containing xanthene bases including red bull, chocolate, coffee, etc. from 48 hours prior to enrollment. 19.Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion (e.g. Diarrhoea). 20.Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the participants unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the bioavailability of ZY-19489 tablet with ZY-19489 capsule administered to healthy participants.Timepoint: Day 0 to Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of ZY-19489.Timepoint: Day 0 to Day 28 | — |
Countries
India
Contacts
Public ContactDr Hardik Patel
Zydus Lifesciences Ltd
Outcome results
None listed