| CTRI Number |
CTRI/2023/05/052877 [Registered on: 18/05/2023] Trial Registered Prospectively |
| Last Modified On: |
29/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence study of Ibuprofen 400 mg tablets of Pinnacle Life Science Pvt. Ltd., in healthy, adult, human subjects. |
|
Scientific Title of Study
|
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Ibuprofen 400 mg tablets of Pinnacle Life Science Pvt. Ltd., In comparison with Brufen® 400 mg Tablets (Ibuprofen 400 mg) of Famar A.V.E Anthoussa Plant Anthoussa in healthy, adult, human subjects under fasting conditions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/052/1022, Version: 00, Dated: 28 Oct 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priya R |
| Designation |
Principal Investigator |
| Affiliation |
ICBio Clinical Research Pvt Ltd |
| Address |
First floor, Clinical Department,
#16&18 ICBio Tower, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
pi.mail@icbiocro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish S |
| Designation |
Director Operation |
| Affiliation |
ICBio Clinical Research Pvt Ltd |
| Address |
#16&18 ICBio Tower, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish S |
| Designation |
Director Operation |
| Affiliation |
ICBio Clinical Research Pvt Ltd |
| Address |
#16&18 ICBio Tower, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Pinnacle Life Science Pvt. Ltd.
Plot No. D-277,278, TTC, M.I.D.C. Industrial Area, Turbhe Navi Mumbai - 400703 |
|
|
Primary Sponsor
|
| Name |
Pinnacle Life Science Pvt. Ltd. |
| Address |
Plot No. D-277,278, TTC, M.I.D.C. Industrial Area,
Turbhe Navi Mumbai - 400703 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Pinnacle Life Science Pvt Ltd |
Plot No. D-277,278,
TTC, M.I.D.C. Industrial Area,
Turbhe Navi Mumbai - 400703 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priya R |
ICBio Clinical Research Pvt Ltd |
Clinical department, first floor, #16&18 ICBio Tower, Yelahanka Main Road,
Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA |
9900111997
pi.mail@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 |
Fasting condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Brufen® 400 mg Tablets (Ibuprofen 400 mg) of Famar A.V.E Anthoussa Plant Anthoussa |
Dose: 400 mg, Dosage form: Tablet, Frequency: single dose, Study duration: 09 days. |
| Intervention |
Ibuprofen 400 mg tablets of Pinnacle Life Science Pvt. Ltd. |
Dose: 400 mg, Dosage form: Tablet, Frequency: single dose, Study duration: 09 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in 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 kg/m2 (both inclusive) |
|
| ExclusionCriteria |
| Details |
1. Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood–forming organs.
2. History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
3. History of severe infection or major surgery in the past 6 months.
4. History of Minor surgery or fracture within the past 3 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cmax and AUC0-t |
Day 01 - Day 09 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| AUC0-∞, Tmax , AUC_%Extrap_obs, λz and t1/2 |
Day 01 - Day 09 |
|
|
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)
|
26/05/2023 |
| 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="9" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None |
|
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 oral dose, crossover,
bioequivalence study of Ibuprofen 400 mg tablets of Pinnacle Life Science Pvt.
Ltd., In comparison with Brufen® 400 mg
Tablets (Ibuprofen 400 mg) of Famar A.V.E Anthoussa Plant Anthoussa in
healthy, adult, human subjects under fasting conditions.
Study Objectives: Primary
objective:
To compare the rate and extent of absorption of Ibuprofen
400 mg tablets of Pinnacle Life Science Pvt. Ltd., with
that of with Brufen® 400 mg Tablets (Ibuprofen
400 mg) of Famar A.V.E Anthoussa Plant Anthoussa in healthy, adult, human
subjects under fasting conditions.
Secondary objective:
To
monitor the safety and tolerability of the study subjects after administration
of Ibuprofen 400 mg tablets under fasting conditions.
Study Duration: 09 Days
|