CTRI/2011/12/002249Other1 期
A randomized, double-blind, placebo-controlled Phase I clinical study toevaluate the safety, tolerability and pharmacokinetics of ZYGK1, anovel Glucokinase Activator, following oral administration in healthyvolunteers
Zydus Research Centre0 个研究点目标入组 96 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- Other
- 发起方
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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
研究者
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