None listed
Conditions
Interventions
Intervention1: Ondansetron extended-release injectable suspension (100
mg/mL): For Cohort I:
Six subjects will receive single dose, Intramuscular administration of
Ondansetron extended-release injecta
Sponsors
Shilpa Medicare Limited
Eligibility
Inclusion criteria
Inclusion criteria: Volunteers must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified. 1. Age: 18 to 45 years old, both inclusive. 2. Gender: Male and/or non-pregnant, non-lactating female. A. Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to dosing day. They must be using an acceptable form of contraception. B. For female of childbearing potential, acceptable forms of contraception include the following: i. Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilization or iv. Practicing sexual abstinence throughout the course of the study. C. Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history: i. Postmenopausal with spontaneous amenorrhea for at least one year, or ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iii. Total hysterectomy and an absence of bleeding for at least 3 months. 3. BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5). 4. Non-smokers and non-tobacco users (i.e., having no history of smoking and tobacco consuming for at least one year prior to study). 5. Volunteers with intact normal skin without obscuring tattoos, pigmentation or lesions 6. Adequate venous access in upper extremities 7. Volunteers with serum hemoglobin within normal range 8. Females of childbearing potential must agree to practice effective birth control for at least 30 days after study completion 9. Able to communicate effectively with study personnel. 10. Willing to provide written informed consent to participate in the study. 11. All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of study medication which will include: a) A physical examination (clinical examination) with no clinically significant finding. b) Results within normal limits or clinically non-significant for the following tests: Hematology, Biochemistry, Urinalysis, Immunological Tests, Serum (β-HCG) pregnancy test (for female of child bearing potential), Creatinine clearance (using Cockcroft-Gault equation)
Exclusion criteria
Exclusion criteria: Volunteers must not be enrolled in the study if they meet any one of the following criteria: 1. History of allergic responses to ondansetron or other 5-HT3 receptor agonists or other related drugs, or any of its formulation ingredients. 2. Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG, chest X-ray recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female volunteers)]. 3. Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system. 4. History or presence of bronchial asthma. 5. Use of any hormone replacement therapy within 3 months prior to the dose of study medication. 6. A depot injection or implant of any drug within 3 months prior to the dose of study medication. 7. Use of CYP enzyme inhibitors or inducers within 30 days prior to the dose of study medication (see http://medicine.iupui.edu/clinpharm/ddis/main-table). 8. History or evidence of drug dependence or of alcoholism or of moderate alcohol use. 9. History of difficulty with donating blood or difficulty in accessibility of veins. 10. A positive hepatitis screen (includes subtypes B & C). 11. A positive test result for HIV antibody and / or syphilis (RPR). 12. Volunteers who have received a known investigational drug within seven elimination half-life of the administered drug prior to the housing. 13. Volunteers who have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or >200 ml within 90 days (excluding volume drawn at screening for this study) prior to dosing of study medication, whichever is greater. 14. Intolerance to venipuncture 15. Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteerâ??s participation in this study. 16. Institutionalized volunteers. 17. Use of any prescribed medications within 14 days prior to housing. 18. Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to housing. 19. Use of grapefruit and grapefruit containing products within 7 days prior to housing. 20. Ingestion of any caffeine or xanthine products (i.e., coffee, tea, chocolate, and caffeine containing sodas, colas, etc.), recreational drugs, alcohol or other alcohol containing products within 48 hours prior to housing. 21. Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to housing. 22. Abdominal surgery within the last 30 days prior to the dose of study medication. 23. History of phenylketonuria. 24. Received ondansetron within 4 days prior to the dose of study medication. 25. History of lower extremity edema. 26. Creatinine clearance values are 27. Dehydration (Grade 2 or higher). 28. Volunteer having QT > 440 ms (for female) or QT > 420 ms (for male) during screening. 29. Female who is pregnant or breastfeeding. 30. Not able to comply with study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish safety (Incidence of study drug-related DLTs) and assessment of tolerability of the test product after single dose administration at dose levels of 35 mg and 70 mg and 100 mg.Timepoint: Blood samples for test arm will be collected at pre-dose (0.0) hours prior to dosing and at 0.167, 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0, 16.0, 24.0, 30.0, 36.0, 42.0, 48.0, 54.0, 60.0, 66.0, 72.0, 78.0, 84.0, 90.0, 96.0, 102.0, 108.0, 114.0, 120.0, 126.0, 132.0, 138.0, 144.0, 150.0, 156.0, 162.0, 168.0, 240.0, 336.0 and 504 hours post dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of Test Formulation and Reference FormulationTimepoint: Blood samples for reference arm will be collected at pre-dose (0.0) hours prior to morning dosing and at 0.167, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0 (before second dosing), 8.167, 8.25, 8.5, 8.75, 9.0, 9.5, 10.0, 12.0, 14.0, 16.0 (before third dosing), 16.167, 16.25, 16.5, 16.75, 17.0, 17.5, 18.0, 20.0, 22.0 and 24.0 hours post morning dosing after the start of infusion. | — |
Countries
India
Contacts
Public ContactP Veerendra Kumar
Cliantha Research Limited
Outcome results
None listed