Bioequivalence study,
Conditions
Interventions
Reference product: Plaquenil® containing hydroxychloroquine sulphate 200 mg per tablet,
Reg. No. 1C 355/2549.
Test product: Generic hydroxychloroquine sulfate containing 200 mg hydroxychloroquine sulfate per tablet.
Active Comparator Drug
Hydroxychloroquine sulphate 200 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 18.0 to 25.0 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 admission. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to admission. 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 until 45 days after the end of study. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to admission: • 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 until 45 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 hydroxychloroquine sulfate, aminoquinoline compounds or any of the other excipients of this product 2 History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological, endocrine, pulmonary or respiratory, cardiovascular, psychiatric, neurologic (e.g. epilepsy), musculoskeletal and connective tissue 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 maculopathy, retinopathy, disturbances of vision or abnormal colour vision 4 History or evidence of glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency), galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 5 History of problems with swallowing tablet 6 History of sensitivity to heparin or heparin-induced thrombocytopenia 7 Any condition possibly affecting drug absorption e.g. oral mucous membrane lesions, gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 8 History of dehydration from diarrhea, vomiting, excess sweating or any other reasons within 24 hours prior to admission or prior to dosing 9 History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 10 Have sitting systolic blood pressure of less than 90 mmHg or more than 139 mmHg and diastolic blood pressure of less than 60 mmHg or more than 89 mmHg on screening day and the day of admission. If abnormal blood pressure detects, the measurement should be repeated two more times after take a rest for at least 5 min each. The last measurement value should be used to determine the subject’s eligibility. 11 Investigation of vital signs shows pulse rate less than 60 or more than 100 beats per minute on screening day or on the day of admission. If abnormal pulse rate detects, the measurement should be repeated two more times after take a rest for at least 5 minutes each. The last measurement value should be used to determine the subject’s eligibility. 12 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. 13 Investigation with blood sample shows positive test for HBsAg. 14 Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test 16 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 17 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 18 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hydroxychloroquine blood concentration 0,1,2,2.5,3,3.33,3.67,4,4.33,4.67,5,5.5,6,7,8,10,12,16,24,48,72 hr post-dose Cmax and Truncated AUC0-72 | — |
Secondary
| Measure | Time frame |
|---|---|
| Hydroxychloroquine blood concentration 0,1,2,2.5,3,3.33,3.67,4,4.33,4.67,5,5.5,6,7,8,10,12,16,24,48,72 hr post-dose Tmax, t1/2 and lamda Z | — |
Countries
Thailand
Contacts
Public ContactPorranee Puranajoti
International Bio Service Co. Ltd.
Outcome results
None listed