Subjects will be admitted the night before investigational product administration,
Conditions
Interventions
a single dose of
pregabalin 150 mg capsule,
Generic,
as a reference formulation (R)
with 240±2 mL of ambient temperature drinking water after an
overnight fasting for at least 8 hours.,a single dose of
pregabalin 150 mg capsule,
LYRICA,
as a reference formulation (R)
with 240±2 mL of ambient temperature drinking water after an
overnight fasting for at least 8 hours.
Active Comparator Drug,Active Comparator Drug
a single dose of pregabalin 150 mg capsule,
Generic,a single dose of pregabalin 150 mg capsule,
Sponsors
Pond Chemical Co., Ltd.
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Age Limit: Minimum 18 Years : Maximum 55 Years 1.Healthy Thai male subjects between the ages of 18 to 55 years. 2.Body mass index between 18.0 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.Male subjects who are willing or able to use effective contraceptive e.g. condoms during sexual intercourse with a woman of childbearing potential or abstinence after admission in Period 1 until at least 10 weeks (one complete sperm cycle) after the last dose of investigational product administration. 5.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 pregabalin or any of the excipients of the product. 2.History or evidence of clinically significant renal, hepatic, gastrointestinal,hematological (e.g. anemia), endocrine (e.g. thyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hypertension, congestive heart failure), psychiatric (e.g. anxiety), neurologic, 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 epilepsy or seizures. 4. History of suicidal thoughts, behavior or suicide attempts in the past 30 days prior to screening or during enrollment in the study. 5. History or evidence of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption. 6. History of problems with swallowing tablet or capsule. 7. History of any bleeding or coagulative disorders. 8. History of sensitivity to heparin or heparin-induced thrombocytopenia. 9. Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy. 10. History of vomiting or diarrhea within 24 hours prior to admission in each period. 11. History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine). 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 will be repeated two more times and the average of the three QTc or QRS values will 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. 15. 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. 16. 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. 17. 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. 18. Consume or drink juice of grapefruit or orange or pomelo 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. 19. Use of prescription (e.g. gabapentin) or nonprescription drugs (e.g. paracetamol, erythromycin, ketoconazole), herbal medications or supplements (e.g. St. John's wort), vitamins or mineral (e.g. iron) or dietary supplements within 14 days prior to admission in Period 1 or during enrollment. 20. Participated in other clinical trials within 90 days prior to admission in Period 1 (except for the subjects who drop out or withdrawn from the previous study prior to Period 1 d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absorption of test and reference drug plasma concentration In each period, total of 19 blood samples will be collected from 18 sampling time points. 2 peroids LC-MSMS | — |
Secondary
| Measure | Time frame |
|---|---|
| Safty of test and reference formulation 8 time points in 72 hrs after administration, 2 periods of administration. 1. Vital sign, 2. Physical examination, 3.Clinical lab examination 4. Advert events monitoring. | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co., Ltd
Outcome results
None listed