| CTRI Number |
CTRI/2023/04/051767 [Registered on: 19/04/2023] 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 Esomeprazole 20 mg Naproxen 500 mg Delayed Release Tablets in healthy adult human subjects under fasting condition |
|
Scientific Title of Study
|
An open label, balanced, randomized, two-treatment, twoperiod, two-sequence,
single oral dose, crossover, bioequivalence study of Esomeprazole 20 mg & Naproxen 500 mg Delayed Release Tablets of Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited) in comparison with Vimovo 20/500 mg Delayed Release Tablets (Esomeprazole
Magnesium 20 mg + Naproxen 500 mg) of AstraZeneca in healthy, adult, human subjects under
fasting condition. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/034/0822 Version 00 Dated 27 Aug 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 |
Ground floor Room no:1 clinical department 16 and 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 and 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 and 18 ICBio Tower Yelahanka Main Road Chikkabetahalli Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited) Plot no. 29-33, Ancillary, Industrial Area, Deonar, Govandi Mumbai - 400043 INDIA |
|
|
Primary Sponsor
|
| Name |
Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited) |
| Address |
Plot no. 29-33, Ancillary, Industrial Area, Deonar, Govandi Mumbai - 400043 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 Priya R |
ICBio Clinical Research Pvt Ltd |
Clinical department Ground floor, room no:1 #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 |
| Intervention |
Esomeprazole 20 mg & Naproxen 500 mg Delayed Release Tablets |
Name of the drug: Esomeprazole 20 mg & Naproxen 500 mg
Route of administration: Oral
Frequency: single oral dose
Duration of clinical study: 11 days |
| Comparator Agent |
Vimovo 20 500 mg Delayed Release Tablets Esomeprazole Magnesium 20 mg Naproxen 500 mg |
Name of the drug: Esomeprazole 20 mg & Naproxen 500 mg Route of administration: Oral Frequency: single oral dose Duration of clinical study: 11 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 30 kg m2 both inclusive
5 Healthy volunteers who are clinically non anemic will be included as per the discretion of PI CI Physician
|
|
| 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
5 Significant history or current evidence of malignancy or chronic infectious cardiovascular renal hepatic ophthalmic pulmonary neurological metabolic endocrine hematological gastrointestinal immunological or psychiatric diseases or organ dysfunction
|
|
|
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 11 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate Pharmacokinetics parameters Tmax , AUC_%Extrap_obs, λz and t1/2 |
From Day 01 to Day 11 |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
01/05/2023 |
| 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="11" |
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 Esomeprazole 20 mg &
Naproxen 500 mg Delayed Release Tablets of Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited) in
comparison with Vimovo 20/500 mg Delayed Release
Tablets (Esomeprazole Magnesium 20 mg + Naproxen 500 mg) of AstraZeneca in healthy, adult, human subjects under
fasting condition.
OBJECTIVES: Primary objective:
To compare the rate and extent of absorption of Esomeprazole 20 mg & Naproxen 500 mg Delayed
Release Tablets of Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited) with that of Vimovo 20/500 mg Delayed Release Tablets (Esomeprazole Magnesium
20 mg + Naproxen 500 mg) of AstraZeneca in
healthy, adult, human subjects under fasting condition.
Secondary
objective:
To
monitor the safety and tolerability of the study subjects after administration
of Esomeprazole Magnesium 20 mg + Naproxen 500 mg tablets in healthy, adult, human subjects under
fasting condition
Number of subjects: Thirty two (32) Duration of clinical study: 11 Days |