Thai healthy male and female subjects ,
Conditions
Interventions
levofloxacin 750 mg tablet,a single oral of generic product,
a new formulation of levofloxacin 750 mg tablet was developed by a company in Thailand
Experimental Drug,Experimental Drug
levofloxacin 750 mg tablet (innovator product),levofloxacin 750 mg tablet (generic product)
Sponsors
Faculty of Medicine, Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence 6 months 90% confidence interval of Cmax, AUC0-t and AUC0-inf | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug concentration in plasma-time profile and pharmacokinetic parameters 6 months Cmax,Tmax, AUC, Half-life (data from the individual concentration vs time) | — |
Countries
Thailand
Contacts
Public ContactPajaree Chariyavilaskul
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed