| CTRI Number |
CTRI/2024/07/071741 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| 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 40 mg MUPS tablets of SunGlow Lifescience Private Ltd with Nexium mups 40 mg gastro resistant tablets (Esomeprazole) of Grunenthal GmbH in healthy adult human subjects under fasting conditions |
|
Scientific Title of Study
|
An Open label, balanced, randomized, two-treatment, twoperiod, two-sequence, single dose, crossover, oral,
bioequivalence study of Esomeprazole 40 mg MUPS tablets of
SunGlow Lifescience Private Ltd with Nexium mups 40 mg
gastro resistant tablets (Esomeprazole) of Grunenthal GmbH in healthy adult human subjects under fasting conditions. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/008/1123, Version: 00, Dated: 03 Nov 2023 |
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 |
No. 2, ICBio Tower-II, Devi Circle, chikkabettahalli, Yelahanka Main Road, vidyaranapura
Bangalore
KARNATAKA
560097
India |
| Phone |
09900111997 |
| Fax |
|
| Email |
headcl@icbiocro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish S |
| Designation |
Managing Director |
| Affiliation |
ICBio Clinical Research Private limited |
| Address |
No. 2, ICBio Tower-II, Devi Circle
chikkabettahalli, Yelahanka Main Road, vidyaranapura
Bangalore
KARNATAKA
560097
India |
| Phone |
09900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish S |
| Designation |
Managing Director |
| Affiliation |
ICBio Clinical Research Private limited |
| Address |
No. 2, ICBio Tower-II, Devi Circle
chikkabettahalli, Yelahanka Main Road, vidyaranapura
KARNATAKA
560097
India |
| Phone |
09900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| SunGlow Lifescience Private Ltd., S.No.208/1A, 208/2A1B, 220/3B, Kattankulam Village, Nelvoy-Thirumukkoodal Road), Uthiramerur (TK) Kanchipuram (Dist.),Pin: 631 606, Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
SunGlow Lifescience Private Ltd |
| Address |
S.No.208/1A, 208/2A1B, 220/3B, Kattankulam Village, Nelvoy-Thirumukkoodal Road), Uthiramerur (TK) Kanchipuram (Dist.),Pin: 631 606, Tamil Nadu, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ms Sunglow Lifescience Private Limited |
Plot No 6, TVDs Flats, United Colony , 2nd Street Medavakkam Chennai (India) - 600100. |
|
|
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 |
No. 2, ICBio Tower-II, Devi Circle, chikkabettahalli, Yelahanka Main Road, vidyaranapura
Bangalore
KARNATAKA |
8023641042
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 |
Fasting condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Esomeprazole 40 mg MUPS tablets |
Name of the drug: Esomeprazole 40 mg MUPS tablets, Route of administration: Oral, Frequency: single oral dose, Study duration:09 days |
| Comparator Agent |
Nexium mups 40 mg gastro resistant tablets (Esomeprazole) |
Name of the drug: Esomeprazole 40 mg MUPS tablets, Route of administration: Oral, Frequency: single oral 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).
5. Healthy volunteers who are clinically non anemic will be included as per the discretion of
PI/CI/Physician. |
|
| ExclusionCriteria |
| Details |
1. Haemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for
women.
2. Any medical or surgical condition, which might significantly interfere with the functioning
of the gastrointestinal tract or blood–forming organs.
3. History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime
in the past.
4. History of severe infection or major surgery in the past 6 months.
5. 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 |
| To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-∞ |
From Day 01 to Day 09 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate Pharmacokinetics parameters Tmax , AUC_%Extrap_obs, λz and t1/2 |
From Day 01 to 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)
|
12/08/2024 |
| 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="9" |
|
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 Esomeprazole 40 mg MUPS tablets of SunGlow Lifescience Private Ltd with Nexium mups 40 mg gastro resistant tablets (Esomeprazole) of Grunenthal GmbH in healthy adult human subjects under fasting conditions
OBJECTIVES:
Primary objective: To compare the rate and extent of absorption of Esomeprazole 40 mg MUPS tablets of SunGlow Lifescience Private Ltd with Nexium mups 40 mg gastro resistant tablets (Esomeprazole) of Grunenthal GmbH in healthy adult human subjects under fasting conditions.
Secondary objective: To monitor the safety and tolerability of the study subjects after administration of Esomeprazole 40 mg MUPS tablets in healthy, adult, human subjects under fasting condition.
Number of subjects: Twenty-four (24) subjects Duration of clinical study: 09 days |