| CTRI Number |
CTRI/2023/02/049405 [Registered on: 02/02/2023] Trial Registered Prospectively |
| Last Modified On: |
07/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence study of Uropass capsule 0.4 mg (Tamsulosin Hydrochloride 0.4 mg capsule) 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 Uropass capsule 0.4 mg (Tamsulosin Hydrochloride 0.4 mg capsule) of The ACME Laboratories Ltd., in comparison with Flomax capsule 0.4 mg (Tamsulosin Hydrochloride 0.4 mg capsule) of Sanofi-Aventis in healthy, adult, human subjects under fasting condition |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/026/0722, Version 01, dated 09 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 |
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
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| The ACME Laboratories Ltd
Court de la ACME 1/4, Kallayanpur Mirpur road Dhaka- 1207 Bangladesh |
|
|
Primary Sponsor
|
| Name |
The ACME Laboratories Ltd |
| Address |
Court de la ACME 1/4, Kallayanpur Mirpur road
Dhaka- 1207 Bangladesh
|
| 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 Harish S |
ICBio Clinical Research Pvt Ltd |
1st floor, clinical department, 16and18 ICBio Tower Yelahanka Main Road Chikkabetahalli Vidyaranyapura
Bangalore
KARNATAKA |
9900111997
harish@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 state |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Flomax capsule 0.4 mg Tamsulosin Hydrochloride 0.4 mg capsule |
Single oral dose |
| Intervention |
Uropass capsule 0.4 mg Tamsulosin Hydrochloride 0.4 mg capsule |
Single oral dose |
|
|
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
6 Any major illness or hospitalization within 90 days prior to check in of first period
7 Any other clinical condition like diarrhea or vomiting within three days prior to check in of any period
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pharmacokinetic parameters Cmax AUC0-t and AUC0- ∞ will be checked |
From baseline Day 01 to day 10 after the dosing |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pharmacokinetic parameters as Tmax AUC_%Extrap_obs λz and t1/2 will be evaluated |
From baseline Day 01 to day 04 after dosing |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/03/2023 |
| Date of Study Completion (India) |
05/02/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
An open label balanced randomized two treatment two period two sequence single oral dose crossover bioequivalence study of Uropass capsule 0.4 mg Tamsulosin Hydrochloride 0.4 mg capsule of The ACME Laboratories Ltd in comparison with Flomax capsuleâ 0.4 mg Tamsulosin Hydrochloride 0.4 mg capsule of Sanofi Aventis in healthy adult human subjects under fasting condition Primary objective To compare the rate and extent of absorption of Uropass capsule 0.4 mg Tamsulosin Hydrochloride 0.4 mg capsule of The ACME Laboratories Ltd with that of Flomax capsuleâ 0.4 mg Tamsulosin Hydrochloride 0.4 mg capsule of Sanofi Aventis in healthy adult human subjects under fasting condition Secondary objective To monitor the safety and tolerability of the study subjects after administration of Tamsulosin 0.4 mg capsules in healthy adult human subjects under fasting condition Twenty four 24 normal healthy adult human subjects will be enrolled for the conduct of bioequivalence study Study duration for BE study of Tamsulosin Hydrochloride 0.4 mg capsule will not exceed 9 days period I check in to last visit of period II |