FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2011/08/001934 [Registered on: 01/08/2011] Trial Registered Retrospectively
Last Modified On: 19/06/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Pilot study to test and validate the applicability of a bioanalytical assay for betahistine in plasma after administration of a single dose betahistine 24 mg IR tablet 
Scientific Title of Study   A pilot study to test and validate the applicability of a bio-analytical assay for betahistine in plasma obtained from healthy male subjects after administration of a single dose of the marketed betahistine 24 mg IR tablet  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
S108.1.107  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alpeshkumar Patel MD 
Designation  Principal Investigator 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Lambda Therapeutic Research Ltd., Plot No. 38, Near Silver Oak Club S. G. Highway, Gota, Ahmedabad - 380 061 Gujarat, INDIA

Ahmadabad
GUJARAT
380061
India 
Phone  07940202282  
Fax  07940202021  
Email  alpeshpatel@lambda-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Alpeshkumar Patel MD 
Designation  Principal Investigator 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Lambda Therapeutic Research Ltd., Plot No. 38, Near Silver Oak Club S. G. Highway, Gota, Ahmedabad - 380 061 Gujarat, INDIA


GUJARAT
380061
India 
Phone  07940202282  
Fax  07940202021  
Email  alpeshpatel@lambda-cro.com  
 
Details of Contact Person
Public Query  
Name  Dr Sakharam Garale 
Designation  clinical operations manager 
Affiliation   
Address  Abbott India Limited 3-4, Corporate Park, Sion - Trombay Road, Mumbai - 400 071. India

Mumbai
MAHARASHTRA
400 071
India 
Phone  9819341363  
Fax  2267978733  
Email  sakharam.garale@abbott.com  
 
Source of Monetary or Material Support  
Abbott Healthcare Products BV C.J. van Houtenlaan 36 1381CP Weesp The Netherlands  
 
Primary Sponsor  
Name  Abbott Healthcare Products BV 
Address  C.J. van Houtenlaan 36 1381CP Weesp The Netherlands  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Alpeshkumar Patel  Lambda Therapeutic Research Ltd  Plot No. 38, Near Silver Oak Club, S. G. Highway, Gota Ahmedabad 380 061 India
Ahmadabad
GUJARAT 		 07940202282

alpeshpatel@lambda-cro.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics committe- Aditya  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pharmacokinetics study 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  it is single arm study 
Intervention  Vertin IR 24 mg  Each tablet contains Betahistine 24 mg  
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Male 
Details  � BMI 18 - 28 kg/m2 
 
ExclusionCriteria 
Details  • Subjects who participated in a previous betahistine trial
• Subjects who can not communicate reliable with the investigator
• Subjects who are unlikely to co-operate with the requirements of the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Cmax, tmax, λz, t1/2, AUC0-t and AUC for both betahistine and metabolite 2-Pyridyl Acetic Acid ;
CL/F and Vz/F for betahistine only
 		 Blood samples for plasma betahistine / 2-PAA PK profiles will be taken on Day 1 / 2 (pre-dose, 0.050, 0.083, 0.167, 0.250, 0.333, 0.416, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 3.000, 4.000, 6.000, 8.000, 10.000, 12.000, 15.000, 18.000 and 24.000 hours post-dose). 
 
Secondary Outcome  
Outcome  TimePoints 
Safety assessments including medical and drug history, physical examination, vital signs, 12-lead ECG, safety laboratory tests,
viral serology, urine drug screen / alcohol breath test  		 Blood samples for plasma betahistine / 2-PAA PK profiles will be taken on Day 1 / 2 (pre-dose, 0.050, 0.083, 0.167, 0.250, 0.333, 0.416, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 3.000, 4.000, 6.000, 8.000, 10.000, 12.000, 15.000, 18.000 and 24.000 hours post-dose). 
adverse event and concomitant medication recording.  Blood samples for plasma betahistine / 2-PAA PK profiles will be taken on Day 1 / 2 (pre-dose, 0.050, 0.083, 0.167, 0.250, 0.333, 0.416, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 3.000, 4.000, 6.000, 8.000, 10.000, 12.000, 15.000, 18.000 and 24.000 hours post-dose). 
 
Target Sample Size   Total Sample Size="8"
Sample Size from India="8" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/07/2011 
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="9" 
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   The aim of the study is to generate plasma samples after single-dose oral administration of betahistine to test and validate a new sensitive bio-analytical assay method measuring betahistine and 2-pyridyleacetic acid (2-PAA) in human plasma. 
Close