| CTRI Number |
CTRI/2022/09/045415 [Registered on: 12/09/2022] 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 Pregabalin 75 mg Duloxetine 30 mg capsule |
|
Scientific Title of Study
|
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Pregabalin 75 mg Duloxetine as delayed release 30 mg capsule of Signature Phytochemical Industries in comparison with Pregalin D 75/30 Pregabalin 75 mg Duloxetine as delayed release) 30 mg Capsule of Torrent Pharma Ltd., in healthy adult human subjects under fasting condition. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/022/0522 version 00 dated 25/02/ 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
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Signature Phytochemical Industries
122 MI, Selaqui Industrial Area, Dehradun (UK)-248 011 |
|
|
Primary Sponsor
|
| Name |
Signature Phytochemical Industries |
| Address |
122 MI, Selaqui Industrial Area,
Dehradun (UK)-248 011
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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. |
#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 |
Healthy, adult, human subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC of Pregabalin 75 mg and Duloxetine 30 mg capsule |
Single dose one time only |
| Comparator Agent |
Pregalin D 30 mg Capsule |
Single dose one time only |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 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.Male subjects have to agree to use condoms during sexual intercourse with a woman of childbearing potential for at least 10 weeks (one complete sperm cycle) after the last dose of study drug.
4.Normal, healthy, adult, human subject of 18-55 years (both inclusive) of age.
|
|
| 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
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the PK parameter Cmax, AUC0-t and AUC0-∞ |
Day 1 to Day 11 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Monitoring of safety of IP
2. Tmax , AUC_%Extrap_obs, λz and t1/2 |
Day 1 to Day 11 |
|
|
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)
|
15/09/2022 |
| Date of Study Completion (India) |
22/08/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="11" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 Pregabalin 75 mg + Duloxetine (as delayed release) 30
mg capsule of Signature Phytochemical Industries in comparison with Pregalin D
75/30 {Pregabalin 75 mg +
Duloxetine (as delayed release) 30 mg Capsule} of Torrent Pharma Ltd., in
healthy, adult, human subjects under fasting condition.
Primary objective:
To compare the rate and extent of absorption of Pregabalin
75 mg + Duloxetine (as delayed release) 30 mg capsule of Signature
Phytochemical Industries with that of Pregalin D 75/30 {Pregabalin 75 mg + Duloxetine (as delayed release) 30 mg
Capsule} of Torrent Pharma Ltd., in healthy, adult, human subjects under fasting
condition.
Secondary objective:
To
monitor the safety and tolerability of the study subjects after administration
of Pregabalin 75 mg + Duloxetine (as delayed release) 30 mg capsules in healthy,
adult, human subjects under fasting condition.
24 subjects will be enroll in the study . The study duration is 11 days .
|