| CTRI Number |
CTRI/2013/09/003964 [Registered on: 06/09/2013] Trial Registered Retrospectively |
| Last Modified On: |
24/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioeqivalence study of Seratrodast 80 mg |
|
Scientific Title of Study
|
A balance, open lable, analyst bind, two treatment, two sequence, single dose bioequivalence study of Seratrodast 80 mg of Zuventus Healthcare Ltd. with BRONICA of Tekeda Pharmaceuticals in 26 healthy, adult, male, human subjects under fasting conditions in randomised, crossover design. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DMRI-PR11-011-SERA Version 00 Dated 10-02-11 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manoj Gautam |
| Designation |
Principal Investigator |
| Affiliation |
Drug Monitoring Research Institute |
| Address |
R-374 MIDC TTC Industrial area Rabale, Navimumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
|
| Fax |
|
| Email |
manojg@dmricro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhupesh Dewan |
| Designation |
DirectornMedical Services |
| Affiliation |
Zuventus Healthcare Ltd |
| Address |
office no 5119, D wing 5th floor, Oberoi Garden Estates, Chandivali, Andheri (E)
Mumbai (Suburban)
MAHARASHTRA
400072
India |
| Phone |
|
| Fax |
|
| Email |
bhupesh.dewan@zuventus.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhupesh Dewan |
| Designation |
DirectornMedical Services |
| Affiliation |
Zuventus Healthcare Ltd |
| Address |
office no 5119, D wing 5th floor, Oberoi Garden Estates, Chandivali, Andheri (E)
MAHARASHTRA
400072
India |
| Phone |
|
| Fax |
|
| Email |
bhupesh.dewan@zuventus.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Zuventus Healthcare Ltd |
| Address |
Office no 5119, D wing 5th floor, Oberoi Garden Estates, Chandivali, Andheri (E) Mumbai- 400072 |
| 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 Manoj Gautam |
Drug Monitoring Research Institute |
R-374, MIDC, TTC Industrial area, Rabale, Navi mumbai 400701
Thane
MAHARASHTRA |
912227642746
manojg@dmricro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jagruti Independent Ethics Committee - Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal healthy adult male subjects under fasting condition. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bronica 80 mg (Seratrodast 80 mg) |
Orally single dose once a day |
| Intervention |
Seratrodast 80 mg |
Orally single dose once in a day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1 healthy humans within 18 to 45
2 weight at least 45 and BMI in range of18.4 - 25.9
3 normal health as determined by medical history and clionical examination, laboratory and othe test mentioned within normal range
5 willingness to provide writtent informed consent to participate in the study
6 willingness to comply with the requirement of protocol including all the restrictions
7 availability of subject during the entire study period |
|
| ExclusionCriteria |
| Details |
1 history of allergy or hypersensitivity to investigational drug
2 abnormilities in vital signs systolic blood pressure < 90 or > 140 mmHg and diostolic blood pressure <50 or >90 mmHg or heart rate <50 bpm or > 100 bpm at screening, pre entry and at pre dose physiccal examination
3 clinically significant cardiovascular, gastrointestinal, liver, renal, pulmonary, hematological, neurological, endocrinal disease
4 History of epilepsy or psychiatric disorder
5 Any illness within 21 days or hospitalized or major illness within three months prior to the first dosing
6 Any other clinical conditions which may be affect absorption, distribution biotransformation or excretion of the study drug
7 Use of any priscribed medication within last two weeks or OTC medical product within last one week preceding first dosing
8 Participated in any other clinical investigation requiring repeted blood sampling/ blood donation program/ have blood lose more than 350 ml from past 90 days
9 History of consumtion of alcohol for more than two years or drink more than two alcohol drinks in a day or consumed alcohol within 48 hrs prior to dosing
10 Smoke more than 10 cigaretts per day or unable to abstain from smoking during study period
11 Consumtion of product containing xanthin and nicotin within 48 hrs before dosing
12 Intake of grapefruits or product containg grape fruits within 72 Hrs prior to receiving the dose of study medication in each period
13 An unusal diet for whatever reson for four weeks prior to receiving study medication
14 Use of any recreational drug or history of drug addiction
15 History of difficulty in vein accessibility |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Seratrodast 80 mgis Bioequivalent to BRONICA 80 mg |
17 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No adverse reaction observed during the study period |
19 days |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/04/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="19" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study was designed to evaluate bioequivalence study of Seratrodast tablets 80 mg for oral administration manufactured by Zuventus Healthcare Limited with BRONICA® Tablets for oral administration manufactured by Takeda Pharmaceuticals ‘ i. Target population for study: Healthy, adult, male, human subjects. A Treatment: Two Test Product: Seratrodast tablets 80 mg. Reference Product: BRONICA® Tablets. Duration of clinical study: 19 days. STUDY OBJECTIVE was to compare the rate and extent of absorption of single-dose of Seratrodast tablets 80 mg of Zuventus Healthcare Ltd. with BRONICA (Seratrodast tablets 80 mg) of Takeda Pharmaceuticals in healthy, adult, male, human subjects under fasting conditions in healthy, adult, male, human subjects under fasting conditions in a randomized crossover design AND to evaluate the safety of single dose of Seratrodast tablets 80 mg |