A clinical study toevaluate the safety, tolerability and pharmacokinetics of oral ZYGK1 in healthy volunteers
- Registration Number
- CTRI/2011/12/002249
- Lead Sponsor
- Zydus Research Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 96
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 45-75 kg 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.
1.Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYGK1 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 more than upper normal limit (UNL) }
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)
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 100 mmHg 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 measures
-History of less than 1 year of menopause and not using adequate long-term anti-fertility measures
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and Tolerability. <br/ ><br>Frequency of adverse events will be assessed at each dose level.Timepoint: Safety and Tolerability[Time Frame: up to 14 days] <br/ ><br>Plan I,III and IV[Time Frame: Up to Day 8 <br/ ><br>Plan II: [Time Frame : Up to Day 14 <br/ ><br>
- Secondary Outcome Measures
Name Time Method Pharmacokinetics and Pharmacodynamics.Effect of food on the phamacokinetics will be assessed in healthyTimepoint: PK[time frame: 7 Days. PK after oral administration of ZYGK1 in PlanI,II,IV:[Time frame:0.25-168 hrs post drug administration] Plan II:[time frame: Day1: 0.25-12 hrs,Day 2-6:0,2,4 hours, Day: 0.25-168 hrs post drug administration. subjects. PD[Time frame: 7 Days]Plan I & III [Time frame: Day 0 and Day 1:upto 4 hrs post oral glucose 75 gm] plan II:[time frame: Day 0, Day 1, & Day 7: upto 4 hours post oral glucose 75 gm plan IV:[time frame: period 2:Day 0 and Day 1:upto 4 hours post meal