| CTRI Number |
CTRI/2023/02/049881 [Registered on: 20/02/2023] Trial Registered Prospectively |
| Last Modified On: |
20/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence study of Mini XL 5mg tablet (Prazosin 5 mg ER tablet) of The ACME Laboratories Ltd. |
|
Scientific Title of Study
|
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Mini XL 5mg tablet (Prazosin 5 mg ER tablet) of The ACME Laboratories Ltd., in comparison with Minipress XL 5mg tablet (Prazosin 5 mg ER tablet) of M/S. Fareva Amboise in healthy, adult, human subjects under fasting condition. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/018/0522, Version 00, Dated 19-MAY-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 |
16and18 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 |
16and18 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 |
16and18 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 Priya R |
ICBio Clinical Research Pvt Ltd |
16and18 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 |
Healthy Subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mini XL 5mg tablet (Prazosin 5 mg ER tablet) |
Dose: single oral dose,
Frequency: single dose for period I or period II,
Route of administration: oral,
Duration of the study: 09 days. |
| Comparator Agent |
Minipress XL 5mg tablet (Prazosin 5 mg ER tablet) |
Dose: single oral dose,
Frequency: single dose for period I or period II,
Route of administration: oral,
Duration of the study: 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 – 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 |
| Pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ will be evaluated |
From baseline Day 01 to Day 09 for each subjects |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pharmacokinetic parameters as Tmax , AUC_%Extrap_obs, λz and t1/2 will be evaluated |
From baseline to 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)
|
22/02/2023 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Mini XL 5mg tablet (Prazosin 5 mg ER tablet) of The ACME Laboratories Ltd., in comparison with Minipressâ XL 5mg tablet (Prazosin 5 mg ER tablet) of M/S. Fareva Amboise in healthy, adult, human subjects under fasting condition.
Primary objective: To compare the rate and extent of absorption of Mini XL 5mg tablet (Prazosin 5 mg ER tablet) of The ACME Laboratories Ltd., with that of Minipressâ XL 5mg tablet (Prazosin 5 mg ER tablet) of M/S. Fareva Amboise in healthy, adult, human subjects under fasting condition. Secondary objective: To monitor the safety and tolerability of the study subjects after administration of Prazosin 5 mg tablets in healthy, adult, human subjects under fasting condition.
Number of subjects: Twenty four (24) |