Bioequivalence Study Healthy Thai Volunteers Cefixime 100 mg Capsules in Healthy Thai Volunteers
Conditions
Interventions
Generic Cefixime 100 mg Capsules, Each capsule contains cefixime trihydrate equivalent to 100 mg of cefixime ,Reference (R): Cefixime 100 mg Capsules, Cefspan, Reg. No. 1A 1/42 (N), manufactured by Bi
Experimental Drug,Active Comparator Drug
Test (T): Generic Cefixime 100 mg Capsules,Reference (R): Cefixime 100 mg Capsules
Sponsors
International Bio Service Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Thai male or female subjects between the ages of 18 to 55 years 2. Body mass index between 18.5 to 30.0 kg/m2 3. Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study. 4. Non-pregnant woman (negative pregnancy test) and not currently breast feeding 5. Female subjects abstain from either hormonal methods of contraception including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period 1. Injectable contraceptives e.g. Depo-Provera will be discontinued at least 6 months prior to check-in in Period 1. Subjects agree to use acceptable nonhormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to check-in in Period 1 until 7 days ayer the end of study in Period 2. Female subjects of nonchildbearing potential must meet at least one of the following criteria prior to check-in in Period 1 - Postmenopausal for at least 1 year or - Surgically sterile (bilateral tubal ligation, bilateral oophorectomy orhysterectomy) at least 6 months 6. Male subjects who are willing or able to use exective contraceptive e.g. condom or abstinence ayer check-in in Period 1 until 7 days ayer the end of study in Period 2. 7. Have voluntarily given written informed consent signed and dated) by the subject prior to participating in this study.
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to cefixime or to any of ingredients in capsules, any other cephem antibiotics or penicillins 2. History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hypo-/hyperthyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hypo-/hypertension), psychiatric (e.g. depression), neurologic (e.g. convulsant), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness 3. Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19 4. History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period 5. History or evidence of muscular disease e.g. muscle pain, tenderness, weakness, myopathy or rhabdomyolysis or hereditary musculardisorders or history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cefixime concentrations 0-24.00 hours post-dose. Cmax, AUC0-tlast and AUC0-infinity | — |
Secondary
| Measure | Time frame |
|---|---|
| Cefixime concentrations 0-24.00 hours post-dose. Tmax, t1/2, AUC0-tlast/AUC0-infinity, AUC%extrapolate, The terminal elimination rate constant and MRT | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co., Ltd.
Outcome results
None listed