Bioequivalence study of levofloxacin 750 mg tablet in Thai healthy volunteers
- Conditions
- Thai healthy male and female subjects ᅉ kg/m2 ,Good health confirming by physical and clinicalAged 18 †50 years ,BMI were within 18-
- Registration Number
- TCTR20190627002
- Lead Sponsor
- Faculty of Medicine, Chulalongkorn University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 26
1. Subjects who are Thai male or female, aged 18 to 50 years, BMI is 18-25 Kg/m2.
2. Subjects who are healthy by medical history, physical examination, vital signs and EKG.
3. Subject whose screening visit laboratory values of blood tests including complete blood count, fasting blood sugar, blood urea nitrogen, serum creatinine, alkaline phosphatase, ALT, AST, total bilirubin, albumin, electrolytes are within the normal range or showing no clinically significant abnormalities as confirmed by the clinical investigator. Hepatitis Bs-antigen and anti-HIV are negative.
4. For female subjects:
Female subject who is in childbearing potential must have serum β-HCG negative and agrees to use an acceptable birth control method from visit 1 to the last visit. The acceptable birth control method is defined as a barrier method of contraception (including condoms, intrauterine device (IUD) and diaphragm with spermicidal agent) or total abstinence from sexual intercourse from visit 1 to the last visit. Hormonal contraceptives are not acceptable.
Female subject
who is in child bearing potential must agree not to become pregnant for the entire participation period and must have a negative result for urine pregnancy test performing prior to dosing at period I and II.
Female subjects can be those with non-childbearing potential which defined as female subjects with hysterectomy, both ovaries removed, surgically sterilized or postmenopausal (for at least 12 consecutive months of amenorrhea)
5. Subjects are able to understand the requirements of the study and voluntarily sign and date an informed consent, approved by the Independent Ethic Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
1. Subjects who are with a history/evidence of drug sensitivity or allergic reaction to levofloxacin, or any related drug.
2. Subjects who have a history of any illness that, in the opinion of the clinical investigator, might confound the result of the study or pose an additional risk in administrating study drug to the subjects. Subjects who have abnormal EKG.
3. Subjects who are with a history of heavy smoking (more than 10 cigarettes per day) or moderate smoking (less than 10 cigarettes per day) and cannot omit smoking at least three days before the study and until the completion of the study period.
4. Subjects who are with a history of alcoholic (more than 2 years) or for women, more than 3 drinks on any single day and more than 7 drinks per week, for men, more than 4 drinks on any single day and more than 14 drinks per week.
5. Subjects who receive of any medical prescription, herbal medicine and food supplement within 14 days before the first administration of the study drug, especially drug related to the study drug metabolizing enzyme. Subjects who are with a history of any drug abuse.
6. Female subjects who are pregnant or breast feeding.
7. Subjects who are participating in any investigational drug study or had been in any investigational drug study within 3 months prior to the screening visit.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bioequivalence 6 months 90% confidence interval of Cmax, AUC0-t and AUC0-inf
- Secondary Outcome Measures
Name Time Method Drug concentration in plasma-time profile and pharmacokinetic parameters 6 months Cmax,Tmax, AUC, Half-life (data from the individual concentration vs time)