| CTRI Number |
CTRI/2024/09/074010 [Registered on: 18/09/2024] Trial Registered Prospectively |
| Last Modified On: |
16/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
NA |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence study of ALGOLIDER 100 mg granules (Nimesulide) with Aulin® 100 mg granules (Nimesulide)in healthy adult human subjects under fed conditions. |
|
Scientific Title of Study
|
An Open label, balanced, randomized, two-treatment, two period, two-sequence, single dose, crossover, oral
bioequivalence study of ALGOLIDER 100 mg granules
(Nimesulide) of Fine Foods & Pharmaceuticals N.T.M. SpA,
Italy with Aulin® 100 mg granules (Nimesulide) of ROCHE
SpA, P.ZZA DURANTE, 11, 20131 MILANO, Italy in healthy adult human subjects under fed conditions. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/023/1023, Version: 01, Dated: 16 Apr 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita Das |
| Designation |
Principal Investigator |
| Affiliation |
ICBio Clinical Research Private limited |
| Address |
Room No: 01, Ground floor, Clinical department, 16 and 18 ICBio Tower, Yelahanka Main Road
Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
08023641042 |
| Fax |
|
| Email |
headcl@icbiocro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish S |
| Designation |
Director |
| Affiliation |
ICBio Clinical Research Private limited |
| Address |
16 and 18 ICBio Tower, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
08023641042 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish S |
| Designation |
Director |
| Affiliation |
ICBio Clinical Research Private limited |
| Address |
16 and 18 ICBio Tower, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura
KARNATAKA
560097
India |
| Phone |
08023641042 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| M/s Icbio Clinical Research Pvt. Ltd, No. 16 ICBio Tower, Chikkabettahalli, Yelahanka Main Road, Vidyaranyapura, Bangalore, India-560097. |
|
|
Primary Sponsor
|
| Name |
EURO LIFECARE LTD |
| Address |
Unit No.511, Hubtown VIVA, Shankarwadi, Western Express Highway, Jogeshwari (East), Mumbai, Mumbai City, MH 400060, India. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankita Das |
ICBio Clinical Research Private limited |
Room No: 01, Ground Floor, Clinical department, 16 and 18 ICBio Tower, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA |
08023641042
headcl@icbiocro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fed condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ALGOLIDER 100 mg granules
(Nimesulide) |
Name of the drug: ALGOLIDER 100 mg granules (Nimesulide), Route of administration: Oral, Frequency: single oral dose, Study duration:10 days. |
| Comparator Agent |
Aulin® 100 mg granules (Nimesulide) |
Name of the drug: Aulin® 100 mg granules (Nimesulide), Route of administration: Oral, Frequency: single oral dose, Study duration:10 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study.
2. Willing to be available for the entire study period and to comply with protocol requirements.
3. Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age.
4. Body mass index in the range of 18.5 – 30.0 kg/m2 (both inclusive).
5. Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, and axillary temperature) measurements at the time screening as well as check-in and check-out during each study period. |
|
| ExclusionCriteria |
| Details |
1. Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and blood–forming organs.
2. History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
3. History of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) in response to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
4. History of hepatotoxic reactions to Nimesulide.
5. History of Concomitant exposure to other potentially hepatotoxic substances. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate Pharmacokinetics parameters: Cmax, AUC0-t and AUC0-∞. |
From Day 01 to day 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate Pharmacokinetics parameters: Tmax, AUC_% Extrap_obs, λz and t1/2. |
From Day 01 to day 10 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
STUDY TITLE:An Open label, balanced, randomized, two-treatment, two period, two-sequence, single dose, crossover, oral bioequivalence study of ALGOLIDER 100 mg granules (Nimesulide) of Fine Foods & Pharmaceuticals N.T.M. SpA, Italy with Aulin® 100 mg granules (Nimesulide) of ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO, Italy in healthy adult human subjects under fed conditions.
OBJECTIVES:
Primary objective: To compare rate and extent of absorption of ALGOLIDER 100 mg granules (Nimesulide) of Fine Foods & Pharmaceuticals N.T.M. SpA, Italy with Aulin® 100 mg granules (Nimesulide) of ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO, Italy in healthy adult human subjects under fed conditions.
Secondary objective: To monitor or assess safety and tolerability of the investigational products in healthy adult human subjects under fed conditions.
Number of subjects: Twenty-four (24) subjects Duration of clinical study: 10 days |