| CTRI Number |
CTRI/2021/01/030599 [Registered on: 19/01/2021] Trial Registered Prospectively |
| Last Modified On: |
31/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
bioequivalence study of Sorafenib 400mg tablet |
|
Scientific Title of Study
|
An open label, randomized, balanced, two treatment, single period, parallel,
single-dose oral bioequivalence study of Sorafenib 400mg tablet of BDR Pharmaceuticals Int
Pvt Ltd India and NEXA VAR 2 X 200 mg Tablets of Bayer HealthCare Pharmaceuticals Inc,
Whippany, NJ 07981, Germany in normal healthy, adult human subjects under fasting
condition. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol number S-20-566 version 01 Dated 30 Sep 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Baby Shalini |
| Designation |
Principal Investigator |
| Affiliation |
Notrox Research Private limited |
| Address |
Notrox Research Pvt Ltd
No.19/3, second floor,
Bikasipura road, Off Kanakapura road,
(Behind Metro cash and carry),
Bangalore district-560062
Karnataka state,
India
Bangalore
KARNATAKA
560062
India |
| Phone |
080-26861077 |
| Fax |
|
| Email |
drshalini@notroxresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Baby Shalini |
| Designation |
Principal Investigator |
| Affiliation |
Notrox Research Private limited |
| Address |
Notrox Research Pvt Ltd
No.19/3, second floor,
Bikasipura road, Off Kanakapura road,
(Behind Metro cash and carry),
Bangalore district-560062
Karnataka state,
India
KARNATAKA
560062
India |
| Phone |
080-26861077 |
| Fax |
|
| Email |
drshalini@notroxresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Baby Shalini |
| Designation |
Principal Investigator |
| Affiliation |
Notrox Research Private limited |
| Address |
Notrox Research Pvt Ltd
No.19/3, second floor,
Bikasipura road, Off Kanakapura road,
(Behind Metro cash and carry),
Bangalore district-560062
Karnataka state,
India
KARNATAKA
560062
India |
| Phone |
080-26861077 |
| Fax |
|
| Email |
drshalini@notroxresearch.com |
|
|
Source of Monetary or Material Support
|
| BDR Pharmaceuticals Internationals Pvt Ltd. India |
|
|
Primary Sponsor
|
| Name |
BDR Pharmaceuticals Internationals Pvt Ltd |
| Address |
BDR Pharmaceuticals Internationals Pvt. Ltd. Engineering Center 6th Floor, 9th Matthew Road, Opera House, Mumbai, India 400004 |
| 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 Baby Shalini |
Notrox Research Private Limited, |
Notrox Research Private Limited,
No, 19/3, second floor, Bikasipura road,
OffKanakapura road (behind Metro cash and carry)
Bangalore 560062
Bangalore
KARNATAKA |
9033966783
drshalini@notroxresearch.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI DURGAMBA INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human Volunteers of age between 18 to 45 years were enrolled in this study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NEXAVAR 2 X 200 mg Tablet |
Single oral dose of NEXAVAR 2 X 200 mg Tablets Manufactured by Bayer HealthCare Pharmaceuticals Inc,
Whippany, NJ 07981,
Germany will be given to healthy subjects. Duration of the study is 4 days |
| Intervention |
Sorafenib 400 mg tablet |
Signle oral dose of Sorafenib 400 mg tablet Manufactured by: BDR Pharmaceuticals Int Pvt
Ltd India will be given to healthy subjects. Duration of the study is 4 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Volunteers who accept for participating in this study must:
1. Healthy, adult human, subjects aged between 18-45 years (both inclusive) weighing at least 50 kg at the time of screening.
2. Having a Body Mass Index (BMI) between 18.50 to 30.00 kg/m2 (both inclusive) at the time of screening.
3. Normal or clinically insignificant findings during screening, medical history, medical examination, laboratory evaluations, 12 lead ECG and X-ray chest (posterior-anterior view) recordings.
4. Able to comply with the study procedures, in the opinion of the principal investigator.
5. Compliance with study specific restrictions and prohibitions.
6. Able to give voluntary written informed consent for participation in the trial.
7. Non-smoker and non-alcoholic
8. Subjects willing to follow approved birth control methods for the duration of the study as judged by the investigator(s), such as condom with spermicide, condom with diaphragm, or abstinence, subjects should also not donate sperm during this time.
|
|
| ExclusionCriteria |
| Details |
If any subject is having any of the following conditions, then exclude him/her from participation in this study:
1. Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.
2. History or presence of any disease or disorder known to influence bone metabolism, compromise the hemopoietin, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, musculoskeletal or any other body system.
3. Systolic blood pressure less than 90 mmHg or more than 140 mmHg at the time of screening. Minor deviations (2-4 mmHg) may be acceptable at the discretion of the physician/investigator.
4. Diastolic blood pressure less than 60 mmHg or more than 90 mmHg at the time of screening. Minor deviations (2-4 mmHg) may be acceptable at the discretion of the physician/investigator.
5. Pulse rate below 60 beats/minute or above I 00 beats/minute at the time of screening.
6. Respiratory rate below 15 or above 20 breaths per minute.
7. Oral temperature below 96.2° For above 99.8 ° Fat the time of screening.
8. Ingestion of any medicine at any time within 14 days prior to IP administration in period I. In any such case subject selection will be at the discretion of the principal investigator.
9. Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).
10. History of dehydration from diarrhoea, vomiting or any other reason within a period of24.00 hours prior to study check-in.
11. An unusual or abnormal diet within 48.00 hours prior to study check-in, whatever reason e.g. because of fasting due to religious reasons.
12. The presence of clinically significant abnormal laboratory values during screening.
13. Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and alcohol breath analysis.
14. A history of difficulty with donating blood or having donated blood in the preceding 90 days prior to the start of the study.
15. Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the 90 days preceding the start of the study.
16. Difficulty in swallowing capsule/tablet.
17. Positive HIV, VDRL/RPR, Hepatitis B and C tests
18. Subjects who have used any drugs or substances known to be strong inhibitors or inducers of Cytochrome P450 enzymes within 14 days prior to IP administration in period I.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cmax and AUC0-72 |
Predose and at 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 08.00, 10.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hours postdose. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tmax |
Same as mentioned in primary outcome. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2021 |
| Date of Study Completion (India) |
25/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not available. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Study was designed as An open label, randomized, balanced two treatment, single period, parallel, single-dose oral bioequivalence study of in healthy, adult, human subjects under fasting condition.
|