None listed
Conditions
Interventions
Intervention1: ZYO1: 20mg tablet and 5mg tablet - Formulation 1
Control Intervention1: ZYO1: 20mg tablet and 5mg tablet - Formulation 2
Sponsors
Cadila Healthcare Limited,
Zydus Tower
Satellite Tower,
Ahmedabad
Eligibility
Inclusion criteria
Inclusion criteria: ? Male subjects aged between 18 and 45 years (including both). ? Subjects? weight within 15% of the ideal height-weight chart of Life Insurance Corporation of India for non-medical cases. ? Ability to communicate effectively with study personnel. ? Willingness to adhere to the protocol requirements. ? Be able to give consent for participation in the trial. ? Normal health as determined by personal medical history, clinical examination and laboratory examinations data during screening (within the clinically acceptable range).
Exclusion criteria
Exclusion criteria: ? Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYO1 formulation. ? History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement. ? History of depression necessitating hospitalization, two or more recurrent episodes of depression, or suicide attempt. ? History or presence of drug addiction or concomitant use of medications known to alter bodyweight or appetite, including anti-obesity drugs, corticosteroids, anti-depressants, neuroleptics, non-selective systemic antihistamines, nicotine substitutes, and antidiabetic drugs in last 30 days. ? History or presence of significant alcoholism or drug abuse within the past one-year. ? History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products. ? Difficulty with donating blood. ? Blood pressure less than 100/70 mm Hg or more than 140/90 mm Hg. ? Pulse less than 55/minute or more than 110/minute. ? Fever or history of fever in last 10 days. ? Evidence of active infection or inflammatory process. ? Any ECG abnormalities. ? Any clinically significant abnormal laboratory values during screening. ? Any clinically significant chest X-Ray findings during screening. ? Major illness during 3 months before the screening period ? Subjects who have participated in drug research studies within past 3 months. ? Subjects who have donated one unit (350ml) of blood in the past 3 months. ? Subjects who are found positive in alcohol breath test and urine test for drug of abuse at the time of check in during both the periods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t, AUC0-inf, Tmax, Volume of distribution, t1/2, AUC_%Extrap_obsTimepoint: 5 min, 10 min, 20 min, 30 min, 45 min, 1.00, 2.00, 4.00, 6.00, 8.00, 12.00, 24.00, 36.00, 48.00, 72.00, 120.00, 168.00, 216.00, and 264.00 hours following drug administration during the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIl | — |
Countries
India
Contacts
Public ContactDr Rajendra H Jani
Cadila Healthcare Limited
Outcome results
None listed