| CTRI Number |
CTRI/2024/10/074789 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
NA |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence study of Pregabalin(PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75 mg+1500 mcg+10 mg) in healthy adult human subjects under fasting conditions. |
|
Scientific Title of Study
|
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study
of Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75 mg+1500 mcg+10 mg) of Unison Pharmaceuticals Private Limited with NeuGaba® MN Tablets [Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75 mg+1500 mcg+10
mg)] Manufactured By: Synokem Pharmaceuticals Limited; Marketed By: Sun Pharma Laboratories Limited in healthy adult human subjects under fasting conditions. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/009/0324, Version: 00, Dated: 04 Mar 2024 |
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 |
Room No:01, Ground floor, Clinical Department, 16 and 18 ICBio Tower, Yelahanka Main Road
Chikkabetahalli, Vidyaranyapura.
Bangalore
KARNATAKA
560097
India |
| Phone |
8069423000 |
| Fax |
|
| Email |
headcl@icbiocro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish S |
| Designation |
Director |
| Affiliation |
ICBio Clinical Research Private limited |
| Address |
16 and 18 ICBio Tower, Yelahanka Main Road,
Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
08023641042 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish S |
| Designation |
Director |
| Affiliation |
ICBio Clinical Research Private limited |
| Address |
16 and 18 ICBio Tower, Yelahanka Main Road,
Chikkabetahalli, Vidyaranyapura
KARNATAKA
560097
India |
| Phone |
08023641042 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Unison Pharmaceuticals Pvt. Ltd., Unison House,
Nr.Prernatirth Derasar, Near
Ratnadeep II, Satellite, Jodhpur, Ahmedabad, Gujarat- 380015, India. |
|
|
Primary Sponsor
|
| Name |
Unison Pharmaceuticals Pvt. Ltd |
| Address |
Unison House, Nr. Prernatirth Derasar, Near Ratnadeep II, Satellite, Jodhpur, Ahmedabad, Gujarat- 380015, India. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ms Unison Pharmaceuticals Pvt Ltd |
C/6, Steel Town, Opp. Nova petro, Moraiya, Ta.-Sanand, Ahmedabad, Gujarat-382213. |
|
|
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 |
Room No: 01, Ground floor, Clinical department, 16 and 18 ICBio Tower, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura.
Bangalore
KARNATAKA |
8069423000
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 |
| Comparator Agent |
NeuGaba® MN Tablets [Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75 mg+1500 mcg+10
mg)] |
Name of the drug: NeuGaba® MN Tablets [Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75 mg+1500 mcg+10
mg)], Route of administration: Oral, Frequency: single oral dose, Study duration:35 days. |
| Intervention |
Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75 mg+1500 mcg+10 mg) |
Name of the drug: Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75 mg+1500 mcg+10 mg), Route of administration: Oral, Frequency: single oral dose, Study duration:35 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of 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 18-55 years (both inclusive) of age.
4. Body mass index in the range of 18.5 – 30.0 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 conditions, which might significantly interfere with the functioning of the gastrointestinal tract and blood–forming organs.
2. History 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 |
1.To evaluate Pharmacokinetics parameters for Nortriptyline, E-10- hydroxynortriptyline and
Mecobalamine Cmax and AUC0-72.
2. To evaluate Pharmacokinetics parameters for Pregabalin Cmax, AUC0-t and AUC0-∞. |
From Day 01 to Day 35 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate Pharmacokinetics parameters for Nortriptyline, E-10- hydroxynortriptyline and
Mecobalamine Tmax.
2. To evaluate Pharmacokinetics parameters for Pregabalin Tmax, AUC0-t/ AUC0-∞, AUC_% Extrap_obs, λz and t1/2. |
From Day 01 to Day 35 |
|
|
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)
|
07/10/2024 |
| 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="1"
Days="5" |
|
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 Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75 mg+1500 mcg+10 mg) of Unison Pharmaceuticals Private Limited with NeuGaba® MN Tablets [Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75 mg+1500 mcg+10 mg)] Manufactured By: Synokem Pharmaceuticals Limited; Marketed By: Sun Pharma Laboratories Limited in healthy adult human subjects under fasting conditions.
OBJECTIVES:
Primary objective: To compare the rate and extent of absorption of Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75mg+1500 mcg+10 mg) of Unison Pharmaceuticals Private Limited with NeuGaba® MN Tablets [Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75mg+1500mcg+10 mg)] Manufactured By: Synokem Pharmaceuticals Limited; Marketed By: Sun Pharma Laboratories Limited in healthy adult human subjects under fasting conditions.
Secondary objective: To monitor the safety and tolerability of the study subjects after administration of Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75mg+1500 mcg+10 mg) in healthy adult human subjects under fasting conditions.
Number of subjects: Twenty-four (24) subjects Duration of clinical study: 35 days |