Healthy male and female subjects Healthy volunteers, Bioequivalence, Venlafaxine 75 mg extended-release capsules, Fed condition
Conditions
Interventions
Each capsule contains 75 mg of venlafaxine in extended-release formulation.,Each capsule contains 75 mg of venlafaxine in extended-release formulation.
Experimental Drug,Active Comparator Drug
VINLAZINE 75 (Venlafaxine 75 mg extended-release capsules),EFEXOR XR (Venlafaxine 75 mg extended-release capsules)
Sponsors
The Government Pharmaceutical Organization
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Non-smokers, normal, healthy, adult male and female subjects between 18 and 55 years of age, both inclusive. 2. Having a Body Mass Index, BMI, between 18.5 and 30.0, both inclusive, calculated as weight in kg divided by height in m2. 3. Subjects whose clinical laboratory values are within normal or acceptable reference ranges or are clinically insignificant during screening, as determined by the physician or Principal Investigator. If any subject has values outside the predefined normal or acceptable range, the study physician or Principal Investigator should have a clearly documented and medically rigorous justification for making that exception. 4. Subjects whose medical history, clinical examination, 12 lead ECG, and chest X-ray recordings, postero-anterior view, are normal or clinically insignificant during screening, as determined by the physician or Principal Investigator. 5. Able to understand and comply with the study procedures, in the opinion of the Investigator. 6. Able to give voluntary written informed consent for participation in the trial. 7. In case of female subjects, the subject must be surgically sterilized at least 6 months prior to study participation, or if of childbearing potential, willing to use a suitable and effective double barrier contraceptive method or intrauterine device during the study, and the urine pregnancy test must be negative.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to venlafaxine, any excipients, any related drug, or any substance. 2. History or presence of any disease or condition that might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, or any other body system. 3. Subjects who are being treated or have previously been treated for any gastrointestinal problems, convulsive disorders, depressive disorders, or hepatic disorders, and in whom there is a risk of recurrence during the study period. 4. Ingestion or use of any medication, including prescribed medication, over the counter medication, OTC medication, herbal remedies, or St Johns Wort, at any time within 14 days prior to dosing of Period 1. In any such case, subject selection will be at the discretion of the Principal Investigator. 5. Any history of bronchospasm, asthma, urticaria, or other allergic type reactions after taking any medication. 6. Consumption of grapefruits or grapefruit products within 72 hours prior to dosing in Period 1. 7. Consumption of xanthine containing food or beverages, including tea, coffee, chocolates, or cola drinks, tobacco, or tobacco containing products within 24 hours prior to IMP administration of Period 1. 8. Smokers or subjects who have smoked within the last 6 months prior to the start of the study. 9. A recent history of harmful use of alcohol within the last 2 years, defined as alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women. A standard drink is defined as 360 mL of beer, 150 mL of wine, or 45 mL of 40 percent distilled spirits, such as rum, whisky, or brandy, or consumption of alcohol or alcoholic products within 48 hours prior to dosing in Period 1. 10. The presence of clinically significant abnormal laboratory values during screening. 11. Use of any recreational drugs, history of drug addiction, or testing positive in pre study drug scans. 12. History or presence of seizure or psychiatric disorder. 13. A history of difficulty with donating blood. 14. Difficulty in swallowing solid dosage forms such as tablets or capsules. 15. Donation of blood, 1 unit or 350 mL, within 90 days prior to the first dose of study medication. 16. PT and aPTT results outside the acceptable range. 17. History or presence of bleeding disorders, active bleeding from any site, or any other clinically significant bleeding risk as judged by the Principal Investigator or Co Investigator. 18. Receipt of an investigational medicinal product or participation in a drug research study within 90 days prior to the first dose of study medication. If the investigational medicinal product was received within 90 days and there was no blood loss except safety laboratory testing, the subject can be included by considering 10 half lives of the investigational medicinal product received. 19. A positive hepatitis screen, including hepatitis B surface antigen and or HCV antibodies. 20. A positive test result for HIV antibody 1 and or 2. 21. An unusual diet, for any reason, such as fasting, high potassium, or low sodium diet, for 4 weeks prior to receiving the study drug in Period 1. In any such case, subject selection will be at the discretion of the Principal Investigator. 22. Nursing mothers, for female subjects. 23. Any history of suicidal behavior and or present positive result on
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters Cmax AUC0 t and AUC0 infinity of venlafaxine following a single oral dose under fasting conditions Pre-dose and up to 72 hours post-dose. Plasma drug concentration determined by validated LC-MS/MS method | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximum plasma concentration (Tmax) and elimination half-life (T1/2) of venlafaxine. Pre-dose and up to 72 hours post-dose Plasma drug concentration determined by validated LC-MS/MS method | — |
Countries
Thailand
Contacts
Public ContactDr. Porranee Puranajoti
International Bio Service Co.,Ltd.
Outcome results
None listed