None listed
Conditions
Interventions
Intervention1: Orlistat 60 mg hard gelatin capsules: Manufactured By: Laboratorios Liconsa S.A (Spain)
Dose in the study: Multiple dose of capsule containing orlistat 60mg (t.i.d.) for 9 consecutive d
Sponsors
GVK Biosciences Pvt Ltd
Laboratorios Liconsa SA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Caucasian subjects, males or females >=18 to day of screening 2. If females: subjects who are willing to use tampon during menstruation 3. Informed Consent Form signed and dated prior to screening procedures. 4. BMI >=25.00 to 5. Physical examination without any clinically relevant abnormality 6. No clinically relevant abnormal laboratory values (as per Annexure 2) 7. Subject who accepts the possible weight loss (approximately 10% change from the baseline) 8. Subjects who are willing to fast overnight each day and consume the repetitively provided standard meals during the whole study 9. Subject able and willing to understand and follow study related procedures
Exclusion criteria
Exclusion criteria: 1. Known allergy or hypersensitivity to orlistat or its derivatives and/or to any study product excipients 2. Any known significant current or past acute or chronic disease or condition of the: circulatory system, respiratory system, hematopoietic system, alimentary tract, urinary tract, endocrine system, nervous system, musculoskeletal system, an allergic disease (excluding allergic rhinitis), genetic disorder or psychiatric disorder that could influence the present general health condition, at the Investigators discretion 3. Current disease of the alimentary tract, liver or kidneys that may influence absorption, distribution and/or elimination of the studied drugs, as assessed by the Investigator and documented in the medical history 4. Current disease of gall bladder and/or cholelithiasis 5. The malabsorption syndrome in medical history 6. Pancreatitis and/or nephrolithiasis in medical history 7. Constipation and/or diarrhea within 1 week before the screening 8. Participation in other clinical trials, where at least one dose of study drug was administered, within 30 days preceding the screening 9. Blood loss or donation exceeding 300 mL within 4 weeks preceding the screening 10. Bradycardia 50 bpm at screening and on day O 11. Tachycardia 100bpm at screening and on day O 12. Blood pressure: systolic 140mmHg or 90mmHg, diastolic 60 mmHg or 90 mmHg at screening and on day O. 13. Body temperature: 36,0°C or 37,5°C on the day of screening and on Day O 14. Abnormal clinical laboratory results assessed by Investigator as clinically relevant (CR) 15. Positive results of HbsAg and/or anti-HCV and/or anti-HIV tests 16. Positive result of stool culture test against Salmonellal Shigella 17. Positive result of the stool ova, cysts & parasites (OCP) test 18. Clinically relevant abnormalities in ECG recording on the day of screening 19. Clinically relevant abnormalities in abdominal USG at screening 20. Current or ex-smoker or tobacco user who has stopped smoking less than six (6) months before screening 21. Pregnant, breast-feeding females 22. History of drug and/or alcohol dependence 23. Subjects who adhere to a special diet (e.g. vegetarian, protein, raw food, etc.) within 30 days preceding day 1 in run out period 24. of the Administration of drugs which may have an influence subjects condition or study results within 4 weeks preceding the first study drug administration. Only the drugs in dose assessed by the Investigator as safe and not having an impact on the study results are allowed within this time (e.g. paracetamol, vitamins) 25. Ingestion of laxatives and/or fat-blocking nutritional supplements within 14 days preceding day 1 in run-in period 26. Positive drug screen or alcohol breath test on day 0 27. Alcohol consumption within 96 hours preceding day 1 in run-in period 28. Consumption of beverages containing caffeine or other methylxanthines (tea, coffee, cola, chocolate, cocoa, energy drinks) in excessive amount (Le. more than 1 liter daily) 29. Any reason the subject is considered by the investigator to be an unsuitable candidate to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The final results will be expressed as: excreted fat (g) per each 24 h sample ingested fat (g) per each 24 h collection PD Parameters FFE24, F (Relative bioavailability), Daily ingested fat, Daily excreted fat, E0 (baseline), ED50, EmaxTimepoint: 24hour | — |
Secondary
| Measure | Time frame |
|---|---|
| Data will be presented in individual listings and summary tables, and evaluated descriptively or by descriptive statistics (mean, SO, median, range) where appropriate. Adverse event analysis for subjects who complete at least one treatment period will be done. AEs causality, intensity and severity will be compared for each test and reference drug in listings and tables (comparison between the drugs of the same strength)Timepoint: Screening and at End of the study | — |
Countries
India
Contacts
Public ContactDr Manjunath
GVK Biosciences Pvt. Ltd.,
Outcome results
None listed