A comparative study to evaluate the two formulations of ZYO1 in healthy volunteers
- Registration Number
- CTRI/2010/091/001473
- Lead Sponsor
- Cadila Healthcare Limited,Zydus TowerSatellite Tower,Ahmedabad
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
? 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).
? 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method ILTimepoint: NIl