Bioequivalence study,
Conditions
Interventions
Telfast® 180 mg,
containing fexofenadine hydrochloride 180 mg per tablet (Reg. No. 1C 60/56 (N)),
manufactured by PT. Aventis Pharma,
Jakarta,
Indonesia and imported by Sanofi-
aventis (Thailand) Ltd.,
Thailand,Generic fexofenadine hydrochloride 180 mg film-
coated tablet,
AVAFAST 180,
containing fexofenadine hydrochloride 180 mg per tablet.
Active Comparator Drug,Active Comparator Drug
Fexofenadine hydrochloride 180 mg film-
coated tablet (Reference product),Fexofenadine hydrochloride 180 mg film-
Sponsors
International Bio Service Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1 Healthy Thai male/female subjects between the ages of 18 to 55 years 2 Body mass index between 18 to 25 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 admission in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to admission in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to admission in Period 1 until 7 days after the end of study. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to admission in Period 1: • Postmenopausal for at least 1 year or • Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months 6 Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after admission in Period 1 until 7 days after the end of study. 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 allergic reaction or hypersensitivity to fexofenadine hydrochloride or any of the components of the product 2 History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological, endocrine, pulmonary or respiratory, cardiovascular, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness 3 History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 4 History of problems with swallowing tablet 5 History of sensitivity to heparin or heparin-induced thrombocytopenia 6 Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 7 History of preceding diarrhea within 24 hrs prior to admission in each period 8 History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 9 12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject’s eligibility. 10 Investigation with blood sample shows positive test for HBsAg. 11 Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test 12 History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period. 13 History or evidence of alcoholism, regular alcohol consumption or alcohol-containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period 14 History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period 15 Consume or drink juice of grapefruit or orange e.g. tangerine or apple or its supplement/ containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period 16 Use of prescription or nonprescription drugs (e.g. antacid, paracetamol, erythromycin, ketoconazole, etc.), herbal medications or supplements (e.g. St John’s wort), vitamin(s) or mineral (e.g. iron) or dietary supplements within 14 days prior to admission in Period 1 or during enrollment 17 Participated in other clinical trial within 90 days or ongoing long-term clinical trial prior to admission in Period 1 (except for the subjects who dropped out/withdrawn from the previous study prior to Period 1 dosing) or during enrollment 18 Blood donation or blood loss ≥1 unit (1 unit is equal to 350-450 mL of blood) within 90 days prior to admission in Period 1 or during enrollment 19 Subjects with poor venous access or intolerant to venepuncture 20 Unwilling or unable to comply with scheduled visits, t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fexofenadine plasma concentrations 0,0.25,0.5,0.75,1,1.25,1.5,1.75,2,2.5,3,3.5,4,6,8,12,24,36,48 hr post-dose Cmax, AUC0-tlast and AUC0-∞ | — |
Secondary
| Measure | Time frame |
|---|---|
| Fexofenadine plasma concentrations 0,0.25,0.5,0.75,1,1.25,1.5,1.75,2,2.5,3,3.5,4,6,8,12,24,36,48 hr post-dose Tmax, t1/2, λz, AUC0-tlast/AUC0-∞, AUC%extrapolate, MRT | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co. Ltd.
Outcome results
None listed