KCT0007258
Recruiting
未知
A phase 1 clinical trial to evaluate the safety and pharmacokinetic characteristics after administration of fixed-dose combination of NGL-101 and loose-combination of each component in healthy adult volunteers
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Chungbuk National University Hospital
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Healthy adult volunteers over the age of 19 at screening
- •2\) Those who weigh more than 50\.0 kg and have a body mass index (BMI) of 18\.0 kg/m2 or more than 30\.0 kg/m2
- •3\) Those who do not have a congenital or chronic disease requiring treatment and who do not have any pathological symptoms or findings as a result of medical examination
- •4\) Those who have been determined to be suitable as a clinical trial subject as a result of clinical laboratory tests and vital signs, physical examination (physical examination), and 12\-lead electrocardiogram that are set and conducted according to the characteristics of the drug for clinical trial at screening
- •5\) After explanation and fully understanding the detailed description of this trial, the person who has voluntarily decided to participate and has agreed in writing to comply with the subject precautions during the trial
Exclusion Criteria
- •1\) Persons with a current or history of clinically significant liver, kidney, nervous system, psychiatric system, respiratory system, endocrine system, blood disease, tumor, genitourinary system, cardiovascular, digestive system, musculoskeletal system, etc., in addition to those with the following or histories:
- •? Patients with type 1 diabetes or diabetic ketoacidosis
- •? Patients with acute kidney injury and renal dysfunction
- •? Patients with hepatic impairment
- •? Patients receiving insulin secretion promoters or diuretics such as insulin and sulfonylurea
- •? Patients at risk of decreased fluid volume and/or hypotension
- •? Patients with bladder underlying disease
- •? Urinary sepsis and pyelonephritis
- •? Genital infections (including fungi)
- •2\) Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose\-galactose malabsorption
Outcomes
Primary Outcomes
Not specified
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