KCT0007757
Completed
未知
A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic characteristics and safety of KD4002 in healthy volunteers under fasting conditions
Kyung Dong Pharmaceutical0 sites40 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Endocrine, nutritional and metabolic diseases
- Sponsor
- Kyung Dong Pharmaceutical
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy adults 19 years of age or older at the time of screening
- •2\. BMI : 17\.5 kg/m2 more than, 30\.5 kg/m2 less than. Male : 55 kg more than / Female : 45 more than
- •3\. Those who have no congenital or chronic diseases within the last 3 years and no pathological symptoms or findings as a result of medical examination
- •4\. Those who are judged to be suitable as test subjects as a result of screening tests conducted by the investigator according to the characteristics of the drug (hematology, blood chemistry, urinalysis, virus/bacterial test, etc.), vital signs, electrocardiogram, etc.
- •5\. Those who have the ability and willingness to participate during the entire examination period
Exclusion Criteria
- •1\. Those who have a history or evidence of clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, psychiatric, neurological, or immune disease (except for simple dental history such as calculus, impacted tooth, wisdom tooth)
- •2\. Those who have a history of gastrointestinal diseases (esophageal diseases such as achalasia or esophageal stricture, Crohn's disease) or surgery (except simple appendicectomy, hernia surgery, and tooth extraction) that may affect drug absorption
- •3\. A person who shows the following values ??as a result of laboratory tests
- •: ALT or AST \- twice the upper limit of the normal range
- •4\. Those with a history of regular alcohol intake exceeding 210 g/week within 6 months of screening
- •5\. Those who have taken other investigational drugs or bioequivalence investigational drugs within 6 months prior to the first administration of the clinical investigational drug
- •6\. Those with a history of serious alcohol or drug abuse within 1 year of screening
- •7\. A person who has taken a drug known to significantly induce or inhibit drug metabolizing enzymes within 30 days before the first administration of the clinical trial drug
- •8\. Smokers who smoked more than 20 cigarettes a day within 6 months of screening
- •9\. Those who have taken prescription or non\-prescription drugs within 10 days prior to the first administration of clinical investigational drugs
Outcomes
Primary Outcomes
Not specified
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