KCT0006146
Recruiting
未知
A clinical study to evaluate the effect of renal impairment of the pharmacokinetics of oral administration of Factive Tablet 320mg(Gemifloxacin mesylate)
ConditionsDiseases of the genitourinary system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the genitourinary system
- Sponsor
- Chonnam National University Hospital
- Enrollment
- 28
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Control group A\-healthy subjects
- •1\) A person who is 19 years of age or older when visiting a screening.
- •2\) A person who does not have clinically meaningful congenital or chronic diseases during a screening visit and does not have any pathological symptoms or findings as a result of an internal examination.
- •3\) A person who weighs more than 50 kg and less than 90 kg and has a BMI of more than 20\.0 kg/m2 and less than 45\.0 kg/m2 during a screening visit.
- •BMI (kg/m2\) \= Weight (kg) / {length (m)}^2
- •4\)A person who has signed a consent form according to his/her free will after hearing and understanding the purpose, contents, characteristics of medicine, and expected adverse reactions.
- •Test groups B, C and D\-subjects with renal impairment
- •1\) A person who is 19 years of age or older when visiting a screening.
- •2\) A person who does not have clinically meaningful congenital or chronic diseases during a screening visit and does not have any pathological symptoms or findings as a result of an internal examination.
- •3\) A person who weighs more than 50 kg and less than 90 kg and has a BMI of more than 20\.0 kg/m2 and less than 45\.0 kg/m2 during a screening visit.
Exclusion Criteria
- •1\) A person who has a history of clinically significant diseases corresponding to digestive systems, cardiovascular systems, endocrine systems, respiratory systems, blood and tumors, infectious diseases, kidney and urinary organisms, mental and nervous systems, musculoskeletal systems, immune systems, otolaryngology, skin systems, and ophthalmology systems.
- •2\) A person who has a history of gastrointestinal surgery (except simple appendectomy or hernia surgery) or has gastrointestinal diseases (cron disease, ulcer, acute or chronic pancreatitis) that can affect the absorption of drugs.
- •3\) Those with a history of tendonitis, tendon rupture, etc. due to investigational drugs and quinolone antimicrobial agents
- •4\) Those who have a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs and other drugs (aspirin, nonsteroidal anti\-inflammatory drugs, antibiotics, etc.) including ingredients such as investigational drugs and quinolone antibiotics
- •5\) Those who showed the following results in the screening
- •\- Those who exceed 2 times the upper limit of the normal range of AST (SGOT), ALT (SGPT)
- •\- Those whose exceed 1\.1 times the upper limit of the normal range of Serun Creatinine level
- •\- Repeatedly measured QTc interval\> 450 ms
- •\- Positive reaction as a result of serum tests (HBs\-Ag, Anti\-HCV Ab, Anti\-HIV, VDRL)
- •\- Those with a history of substance abuse
Outcomes
Primary Outcomes
Not specified
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