None listed
Conditions
Interventions
Intervention1: ZYOG1: From 10mg Oral administration OD
Control Intervention1: Placebo: Once daily
Sponsors
Cadila Healthcare Limited
Zydus Tower
Satellite Cross Rd
Ahmedabad - 380015, Gujarat
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18-45 years 2. Mentally, physically, and legally eligible to give informed consent 3. Male and female volunteers weighing between 50-75 kg and 45-75kg respectively 4. Ability to communicate effectively with the study personnel 5. Willingness to adhere to the protocol requirements 6. For gender effect study, only females with history of sterility or at least 1 year menopause or use of long acting nonhormonal contraceptive measures (e.g., intrauterine device) will be recruited
Exclusion criteria
Exclusion criteria: 1. Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYOG1 formulation 2. Presence or history of pancreatitis at any time (Serum Amylase/Serum Lipase more than upper normal limit (UNL)) 3. Presence or history of severe gastrointestinal disease in the last 6 months 4. Presence or history of renal insufficiency at any time (serum creatinine >1.5 mg/dL) 5. Active liver disease and/or liver transaminases greater than 1.5 X UNL 6. History or presence of other systemic disorders or diseases (e.g.,respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement) 7. Abnormal bleeding time (BT), clotting time (CT), prothrombin time (PT), and activated partial prothrombin time (APTT) tests on the day of check in 8. History or presence of any medication in the last 14 days 9. History or presence of significant alcoholism or drug abuse within the past 1 year 10. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products (more than 10 times per day) 11. Difficulty with donating blood 12. Systolic blood pressure more than 140 mmHg and less than 100mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg 13. Pulse rate less than 60/minute and more than 100/minute 14. Any clinically significant abnormal X-ray or laboratory findings during screening 15. History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening 16. Major illness and/or major surgery in last 3 months 17. Volunteers who have participated in any drug research study other than the present trial within past 3 months 18. Volunteers who have donated one unit (350 ml) of blood in the past 3 months 19. For gender effect study, female volunteers with following criteria will not be recruited: - History of pregnancy or lactation in the past 3 months - Fertile female volunteers not protected against pregnancy by adequate long-term anti-fertility device or history of less than 1 year of menopause - Using hormonal contraceptives - Using hormone replacement therapy - Unable to give assurance for protection against pregnancy for 3 months after the participation in this trial - Positive urine pregnancy test on the day of check-in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate- 1. Safety and tolerability 2. Pharmacokinetics (PK) after single and multiple oral dose administrations in healthy adult male volunteers 3. Pharmacodynamic (PD) effect after single and multiple oral dose administrations in healthy adult male volunteers 4. Gender effects: Pharmacokinetics, pharmacodynamic effect and safety parameters in female volunteers at preselected single dose will be compared with the results of single-dose study in male volunteers 5. Effect of food on pharmacokinetics in male volunteers.Timepoint: 1.Prior to each dosing on Day 02, 04, 06 2. Blood Sampling for PK (Plan I, III, IV)- Pre dose (before dosing), 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hrs, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 24 hrs and 48 hrs following drug administration. For Plan II -Day 01: pre dose, 0.25,0.5, 0.75, 1, 1.5, 2, 3, 4 and 8 hours of first dosing. Day 02 to Day 06: pre dose of each dosing. Day 07: Pre dose, 0.25,0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 and 48 hours of last dosing 3.Blood Sampling for PD (Plan I, III, IV) - Day 0: 24.5, 23.5, 23, 22.5 and 22 hours before dosing Day 01: Pre dose (30 minutes before dosing), 0.5, 1, 1.5 and 2 hours post dose. For Plan II - Day 0: 24.5, 23.5, 23, 22.5 and 22 hours before each dosing of Day 01 Day 01 and 07: Pre dose (30 minutes before each dosing), 0.5, 1, 1.5, and 2 hours post dose (after each dosing) | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr RH Jani
Cadila Healthcare Limited
Outcome results
None listed