Bioequivalence Study of 100 mg Cefixime Capsules in Healthy Thai Volunteers
- Conditions
- Healthy volunteers
- Registration Number
- TCTR20170814002
- Lead Sponsor
- Millimed BFS Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
1) Male and female subjects age between 18-45 years
2) Body Mass Index (BMI) between 18.5-25.0 kg/m2 and body weight not less than 45 kg
3) Healthy subjects based on medical history and physical examination
4) Normal or not clinically significant abnormal of clinical laboratory results including blood urea nitrogen (BUN), serum creatinine (SCr), AST, ALT, total bilirubin, direct bilirubin, alkaline phosphatase, total protein, fasting blood glucose, complete blood count and urinalysis
5) Clinical laboratory result of hepatitis B is negative
6) No clinically significant findings in vital sign measurement
7) Nonsmoker or stop smoking for at least 6 months
8) Females who participate in this study are:
8.1) Nonpregnant female (negative result for pregnancy test)
8.2) With childbearing potential, whom must commit to using
acceptable non-hormonal contraceptive method of birth control for
at least 2 weeks before and during the study and 2 weeks after
drug administration in period 2 as judged by the clinical
investigators, such as condoms, non-hormonal intrauterine device
(IUD), or willing to remain abstinence (not engage in sexual
intercourse)
8.3) Not currently breast feeding
9) Subjects are able, willing, and likely to comply with study procedures and restrictions.
1) Subjects with a history of allergy to cefixime or related structure of cefixime or other components in the formulation
2) Subjects who demonstrated allergic-type reaction of penicillins, cephalosporin class of antibiotic
3) Subjects with currently or history of alcohol addiction or drug abuse
4) Subjects with currently or history of severe asthma, lung disease, seizures, gastrointestinal bleeding or ulcer, heart rhythm problem, hepatic, renal, endocrine, or cardiovascular diseases or any other conditions that may affect bioavailability of the medication or safety of the subjects
5) Subjects who use of any medication including vitamins, herbal products, and dietary supplement, within 14 days before and during the study
6) Subjects who are unable to refrain from consumption of orange, pamelo, grapefruit within 7 days before and during the study
7) Subjects who are unable to refrain from caffeine-containing beverages and foods such as tea, coffee, cocoa, cola, chocolate or energy drink for 3 days before and during the study
8) Subjects with positive urine drug abuse test (methamphetamine, cannabinoid and opiates)
9) Subjects with positive alcohol breath test
10) Subjects with a history of blood donation greater than 300 ml or significant blood loss within 90 days before the initiation of the study
11) Subjects who participate in other clinical trials within 90 days before the initiation of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cefixime concentration in plasma 0.0, 1.0, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 10.0, 12.0, 24.0, 36.0, and 48.0 h Cmax, AUC(0-tlast), AUC(0-inf),Area Under the Plasma Concentration Time Curve From 0-tlast (AUC0-tlast) of Cefixime 0.0, 1.0, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 10.0, 12.0, 24.0, 36.0, and 48.0 h LC-MS/MS,Area Under the Plasma Concentration Time Curve From 0-inf (AUC0-inf) of Cefixime 0.0, 1.0, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 10.0, 12.0, 24.0, 36.0, and 48.0 h LC-MS/MS
- Secondary Outcome Measures
Name Time Method /A N/A N/A