None listed
Conditions
Interventions
Intervention1: Fixed dose combination of Naltrexone Hydrochloride and Zonisamide Sustained Release Capsules.: Fixed dose combination of Naltrexone Hydrochloride and Zonisamide Sustained Release Capsul
Sponsors
Dr Reddys Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Normal healthy, adult, human subjects, age between 18 to 45 years (inclusive of both). 2. Body mass index of ï?³ 18.5 kg/m2 and ï?£ 24.9 kg/m2 and weight ï?³ 50.00 kg. 3. Healthy according to the laboratory results and physical examination, performed within 21 days prior to the commencement of the dosing of the study period. 4. Subject whose clinical laboratory values are within normal limits or clinically insignificant as determined by physician or principal investigator to be of no clinical significance. 5. Have clinically acceptable ECG, Chest X-ray and vital signs 6. Non-Alcoholics. 7. Non-smoker 8.Subject able to communicate effectively and willing to provide written informed consent 9. Subject willing to adhere to protocol requirements as evidenced by written informed consent approved by an Independent Ethics Committee (IEC). 10. If study subject is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence: Or is postmenopausal for at least 1 year Or is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study subject). 11. Male subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as (a double barrier method) Condom with spermicide, Condom with diaphragm, or abstinence. 12. Male subjects willing to agree not to donate sperm during the study.
Exclusion criteria
Exclusion criteria: 1. Any history of allergy or hypersensitivity to Naltrexone Hydrochloride and Zonisamide or any of its excipients or other related drugs. 2. Positive test result for hepatitis B surface antigen (HBs Ag), hepatitis C virus antibody (HCV Ab) or HIV-1 antibody or HIV Type 2 (HIV-2) antibody (HIV Ab) or VDRL / syphilis. 3.The study drug is contraindicated for medical reasons. 4. Any history or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, dermatological, neurological, psychiatric and Eye diseases or disorders. 5. History or presence of seizures, movement disorders, significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour. 6. History or presence of cancer 7. History or presence of significant easy bruising or bleeding. 8. History or presence of significant recent trauma. 9. Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study. 10. History or presence of significant gastric and/or duodenal ulceration. 11. Consumption of xanthine-containing products, tobacco containing products within 48 hours and grapefruit or grapefruit juice within 72 hours prior to dosing of period 1. 12. Use of any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month prior to dosing. 13. Amenorrhea or irregular menstrual periods (defined unable to predict within 7 days) during past 6 months for females. 14. History or presence of drug abuse in the past one year. 15. Difficulty in swallowing tablets or capsules. 16. Any history of difficulty in donating blood. 17. Had clinically significant abnormal values of laboratory parameters 18. Subject having Modified Patient Health Questionnaire (PHQ) 12 questionnaires >4 19. Blood pressure is 129/79 millimeters of mercury (Systolic blood pressure/ Diastolic blood pressure). 20. Pulse rate less than 60 beats / minute and more than 100 beats / minute. 21. Usage of any prescribed medication during last 14 days and for OTC medicinal products, herbal products during the last 07 days preceding first dosing of the study. 22. Female subject who is currently breast feeding or a female study subject who is pregnant or who is likely to become pregnant during the study. 23. Female subject demonstrating positive for pregnancy test (performed at the time of each period check-in). 24. Any clinically significant illness during 3 months before screening. 25. Participation in a drug research study/donation of blood within past 90 days. 26. Consideration by the investigator, for any reason that the subject is an unsuitable candidate to receive study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)To evaluate comparative pharmacokinetics and bioavailability of the reference product, after administering alone as well as in combination under fasting condition.Timepoint: Blood collection will be done at pre-dose (0 hour) to 264 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety and tolerability of the subjects.Timepoint: Blood collection will be done at pre-dose (0 hour) to 264 hours | — |
Countries
India
Contacts
Public ContactD Pradeep
Dr. Reddyâ??s Laboratories Ltd.
Outcome results
None listed