| CTRI Number |
CTRI/2011/12/002292 [Registered on: 26/12/2011] Trial Registered Retrospectively |
| Last Modified On: |
10/04/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
Pharmacodynamic Equivalence study |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A randomized, open-label, multiple dose, four-way crossover pharmacodynamic equivalence study comparing
Orlistat 60mg and 120mg hard gelatin capsules in healthy
volunteers. |
|
Scientific Title of Study
|
A randomized, open-label, multiple dose, four-way cross-over pharmacodynamic equivalence study comparing orlistat 60 mg and 120 mg hard gelatin capsules [Orlistat (Laboratorios Liconsa S.A. vs alli® (Glaxo Group Limited) and Xenical® (Roche Registration Limited)] in healthy volunteers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| A137-11, Version No. 01 dated 29th July 2011 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Hari Emmadi |
| Designation |
Clinical Project Management |
| Affiliation |
GVK Biosciences Pvt. Ltd. |
| Address |
Clinical Pharmacology Unit-2
Vedant, Near YMCA Club,
S. G. Highway
Ahmadabad
GUJARAT
380051
India |
| Phone |
079-61904626 |
| Fax |
079-61904646 |
| Email |
hari.emmadi@gvkbio.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunath |
| Designation |
Investigator |
| Affiliation |
GVK Biosciences Pvt. Ltd., |
| Address |
Clinical Pharmacology Unit-2
Vedant, Near YMCA Club,
S. G. Highway
Ahmadabad
GUJARAT
380051
India |
| Phone |
079-61904603 |
| Fax |
079-61904646 |
| Email |
manjunath.adalegere@gvkbio.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjunath |
| Designation |
Investigator |
| Affiliation |
GVK Biosciences Pvt. Ltd., |
| Address |
Clinical Pharmacology Unit-2
Vedant, Near YMCA Club,
S. G. Highway
Ahmadabad
GUJARAT
380051
India |
| Phone |
079-61904603 |
| Fax |
079-61904646 |
| Email |
manjunath.adalegere@gvkbio.com |
|
|
Source of Monetary or Material Support
|
| Laboratorios Liconsa SA
Quintanapalla 2, (4th floor)
28050 Madrid, Spain
Phone: + 34 91 771 15 00
Fax: : +3491 7668963 |
|
|
Primary Sponsor
|
| Name |
Laboratorios Liconsa SA |
| Address |
Quintanapalla 2, (4th floor)
28050 Madrid, Spain
Phone: + 34 91 771 15 00
Fax: : +3491 7668963 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| GVK Biosciences Pvt Ltd |
CLINICAL PHARMACOLOGY UNIT-2, VEDANT, NEAR YMCA CLUB, S. G. HIGHWAY, AHMEDABAD-380 051, INDIA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravi Chodankar |
Goa Scan Centre |
C/0 - Chodankar
Hospital, NH-17
Bipass, Porvorim,
Panaji GOA
North Goa
GOA |
08322417778
08322417778
chodankarhospital@gmail.com |
| Dr Bhalchandra Naik Desai |
Kamat Criti Care & Research Center |
Margao
South Goa
GOA |
08322711111
08322705555
kamatcriticare@gmail.com |
| Dr Digambar Naik |
Vrundavan Hospital Research Center |
Panjim & Mapusa
North Goa
GOA |
08322250022
08322250305
research@vrundavanhospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| IBIOME IEC (Ahmedabad) Dr Chodankar |
Approved |
| IBIOME IEC (Ahmedabad) Dr Desai |
Approved |
| IBIOME IEC (Ahmedabad) Dr Naik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers on ORLISTAT |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
alli® 60 mg hard capsules |
Manufacturer: Famar, 190 11 Avlona, Greece
Marketing Authorisation Holder: Glaxo Group Limited, United Kingdom
Dose in the study: Multiple dose of capsule containing orlistat 60mg (t.i.d.) for 9 consecutive days of one treatment period |
| Intervention |
Orlistat 120 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 days of one treatment period |
| Intervention |
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 days of one treatment period |
| Comparator Agent |
Xenical® 120 mg hard capsules |
Manufactured By: Roche Pharma AG
Marketing Authorisation Holder: Roche Registration Limited (United Kingdom)
Dose in the study: Multiple dose of capsule containing orlistat 120mg (t.i.d.) for 9 consecutive days of one treatment period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy Caucasian subjects, males or females ≥18 to ≤55 years old on the ."
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 ≤30.00 kg/m2 (the minimum body weight for male subjects must be 70 kg, for female subjects - 60 kg)
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 |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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, Emax |
24hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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) |
Screening and at End of the study |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/12/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To investigate the pharmacodynamic equivalence of orlistat, using fat excreted in feces, from a new formulation of orlistat: Orlistat 60 mg hard gelatin capsules and Orlistat 120 mg hard gelatin capsules (Laboratorios Liconsa S.A, Spain) with the reference formulation alli® 60 mg hard capsules and Xenical® 120 mg hard capsules following multiple dose administration (three times a day) of each test and reference product to healthy subjects.
To evaluate the safety and tolerability of the formulations specified above |