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CTRI Number  CTRI/2012/03/002485 [Registered on: 07/03/2012] Trial Registered Prospectively
Last Modified On: 24/06/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Crossover Trial 
Public Title of Study   a clinical trial to assess the safety, tolerability and pharmacokinetics of enteric coated compound B09 in healthy male subjects 
Scientific Title of Study   A randomized, double-blind, active-controlled, cross over, single dose study to assess the safety, tolerability and pharmacokinetics of enteric coated compound B09 in healthy male subjects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CLR_09_04  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Mudgal Kothekar MD 
Designation  Associate Vice President Clinical Development 
Affiliation  Sun Pharma Advanced Research Company Ltd. 
Address  17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri East.

Mumbai
MAHARASHTRA
400093
India 
Phone  912266455645  
Fax    
Email  Clinical.Trials@sparcmail.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Mudgal Kothekar MD 
Designation  Associate Vice President Clinical Development 
Affiliation  Sun Pharma Advanced Research Company Ltd. 
Address  17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri East.

Mumbai
MAHARASHTRA
400093
India 
Phone  912266455645  
Fax    
Email  Clinical.Trials@sparcmail.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Mudgal Kothekar MD 
Designation  Associate Vice President Clinical Development 
Affiliation  Sun Pharma Advanced Research Company Ltd. 
Address  17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri East.

Mumbai
MAHARASHTRA
400093
India 
Phone  912266455645  
Fax    
Email  Clinical.Trials@sparcmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Sun Pharma Advanced Research Company Ltd 
Address  17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai 400093, India. 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aman Khanna  Sun Pharmaceutical Industries Ltd  Tandalja,India– 390 020
Vadodara
GUJARAT 		 91-265-2350789
91-265-2354897
Aman.Khanna@sunpharma.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vadodara Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  It is indicated for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis (MS) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  B09 EC  Single oral dose of B09 EC, 35 mg Duration:given only once 
Comparator Agent  Baclofen  Single oral dose of Baclofen, 20 mg Duration:given only once 
Comparator Agent  Baclofen EC   Single oral dose of Baclofen EC (enteric coated), 20 mg Duration:given only once 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1.Availability of subject for the entire study period and willingness to adhere to protocol requirements.
2.Healthy male subjects, 18 to 45 years of age, subjects having weight at least 50Kg and the subject’s body mass index (BMI) must be within 18.5 – 25.0 (Kg/m2) (inclusive).
3.Subjects who have no evidence of underlying disease during screening medical history and whose general examination is performed within 21 days prior to commencement of the study.
4.Subjects whose screening laboratory values are within normal limits or considered by the Principal Investigator/Sub-Investigator to be of no clinical significance.
5.Informed consent form given in written form
 
 
ExclusionCriteria 
Details  1.History or presence of significant:
1.1Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Baclofen and/or any related compounds etc.
1.2Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
1.3Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year.
1.4Smoking (≥ 10 cigarettes/day) or consumption of tobacco products (≥ 4 chews/day).
1.5History of difficulty in swallowing or coming for follow up.
1.6Clinically significant illness within 4 weeks before the start of the study
1.7Subjects who have been on an abnormal diet (for whatever the reason) during the four weeks preceding the study
1.8Positive result to HIV, HCV and HBs-Ag.
1.9Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine etc.) in the previous 30 days before day 1 of this study.
1.10Abnormal 12 lead ECG, X-ray.
2.Donation of 350 ml or more of blood in the previous 90 days before day 1 of this study.
3.Participation in another clinical trial within the preceding 90 days of study starts.
4.Subjects who have:
4.1Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
4.2Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations ( 2-4mm Hg) at check-in may be acceptable at the discretion of the principal investigator.
4.3Pulse rate below 60/min. or above 100/min.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Adverse events, vital signs, clinical laboratory tests, ECG  Baseline, Check-in of each period, Post study within 14 days 
 
Secondary Outcome  
Outcome  TimePoints 
Pharmacokinetics parameters  pre-dose, 0.167, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12, 16, 20, 24, 36 hours after dose for each period 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   12/03/2012 
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="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

It is a randomized, double-blind, active-controlled, cross over, single dose study to assess the safety, tolerability and pharmacokinetics of enteric coated compound B09 in healthy male subjects

 

The objective of this study is to monitor the safety of the subjects participating in the study and to assess the tolerability and pharmacokinetics of the enteric coated compound B09 of Sun Pharma Advanced Research Company Limited (SPARC Ltd.), India given as single dose in 12 healthy male subjects.

 
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