Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Age: 18-45 years
Mentally, physically, and legally eligible to give informed consent
Male and female volunteers weighing between 50-75 kg and 45-75 kg respectively
Ability to communicate effectively with the study personnel
Willingness to adhere to the protocol requirements
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:

Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYD1 formulation
Presence or history of pancreatitis at any time (Serum Amylase/Serum Lipase more than upper normal limit (UNL))
Presence or history of severe gastrointestinal disease in the last 6 months
Presence or history of renal insufficiency at any time (serum creatinine above the upper limit of the reference range)
Active liver disease and/or liver transaminases greater than 1.5 X UNL
Subject with personal or family history of medullary thyroid cancer
Subject with personal or family history of multiple endocrine neoplasia syndrome type 2
Subject with serum calcitonin >50 ng/L
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)
Abnormal bleeding time (BT), clotting time (CT), prothrombin time (PT), and activated partial prothrombin time (APTT) tests on the day of check in
History or presence of any medication in the last 14 days including any medication known to interact with the Cytochrome P (CYP) 450 system
History or presence of significant alcoholism or drug abuse within the past 1 year
History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products (more than 10 times per day)
Difficulty with donating blood
Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg
Pulse rate less than 60/minute and more than 100/minute
Any clinically significant abnormal X-ray or laboratory findings during screening
History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening
Major illness and/or major surgery in last 3 months
Volunteers who have participated in any drug research study other than the present trial within past 3 months
Volunteers who have donated one unit (350 ml) of blood in the past 3 months

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