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CTRI Number  CTRI/2022/06/043263 [Registered on: 14/06/2022] Trial Registered Prospectively
Last Modified On: 07/03/2023
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence study on fixed dose combination of Tramadol hydrochloride 37.5 mg and Acetaminophen 325 mg effervescent tablet in healthy adult subjects in fasting condition  
Scientific Title of Study   An open label, balanced, randomized, two-treatment, two-sequence, two-period, single oral dose, crossover, bioequivalence study on fixed dose combination of Tramadol hydrochloride 37.5 mg and Acetaminophen 325 mg effervescent tablet from SciTech Specialities Pvt. Ltd. (Test) Vs Tramacet® 37.5 mg/325 mg effervescent tablet (Tramadol hydrochloride 37.5 mg and Acetaminophen 325 mg) of Grunenthal GmbH (Reference), in healthy, adult, human subjects under fasting conditions 
Trial Acronym  NIl 
Secondary IDs if Any  
Secondary ID  Identifier 
ICBio/022/0721 version 02 dated 27 May 2022   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priya R  
Designation  Principal Investigator 
Affiliation  ICBio Clinical Research Pvt. Ltd. 
Address  #16 &18, ICBio Tower, Chikkabettahalli, Yelahanka Main Road, Vidyaranyapura

Bangalore
KARNATAKA
560097
India 
Phone  23641042   
Fax    
Email  pi.mail@icbiocro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harish S  
Designation  Director Operation  
Affiliation  ICBio Clinical Research Pvt. Ltd.  
Address  #16 & 18 ICBio Tower, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax    
Email  harish@icbiocro.com  
 
Details of Contact Person
Public Query  
Name  Dr Harish S  
Designation  Director Operation  
Affiliation  ICBio Clinical Research Pvt. Ltd.  
Address  #16 & 18 ICBio Tower, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax    
Email  harish@icbiocro.com  
 
Source of Monetary or Material Support  
SciTech Specialities Pvt. Ltd. 501, DLH Park, S.V. Road, Goregaon (W) Mumbai  
 
Primary Sponsor  
Name  SciTech Specialities Pvt Ltd 
Address  501, DLH Park, S.V. Road, Goregaon (W) Mumbai  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Priya R   ICBio Clinical Research Pvt. Ltd.   #16 & 18 ICBio Tower, Yelahanka Main Road, Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA 		 9900111997

pi.mail@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  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy adult human subjects  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Tramacet® 37.5 mg/325 mg effervescent tablet   single oral dose, one time only 
Intervention  Tramadol hydrochloride 37.5 mg and Acetaminophen 325 mg  single oral dose, one time only  
 
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 – 30 kg/m2 (both inclusive).
5.Normal haemoglobin between 12.5 to 17.5 grams per deciliter (g/dL) for men and 12.0 to 16.0 g/dL for female.
 
 
ExclusionCriteria 
Details  1.Found Positive (+Ve) on Rapid antigen test for COVID-19 during screening.
2.Haemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women.
3.Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and blood–forming organs.
4.History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
5.History of severe infection or major surgery in the past 6 months.
6.History of Minor surgery or fracture within the past 3 months.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Cmax, AUC0-t and AUC0-∞  Day 1 to day 3  
 
Secondary Outcome  
Outcome  TimePoints 
Tmax , AUC_%Extrap_obs, λz and t1/2  Day 1 to day 3  
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/06/2022 
Date of Study Completion (India) 22/08/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIl 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

An open label, balanced, randomized, two-treatment, two-sequence, two-period, single oral dose, crossover, bioequivalence study on fixed dose combination of Tramadol hydrochloride 37.5 mg and Acetaminophen 325 mg effervescent tablet from SciTech Specialities Pvt. Ltd. (Test) Vs Tramacet® 37.5 mg/325 mg effervescent tablet (Tramadol hydrochloride 37.5 mg and Acetaminophen 325 mg) of Grunenthal GmbH (Reference), in healthy, adult, human subjects under fasting conditions.


Primary objective:

To compare rate and extend of orally administered molecule to find out concentration on biological fluid of fixed dose combination of Tramadol hydrochloride 37.5 mg and Acetaminophen 325 mg effervescent tablet from SciTech Specialities Pvt. Ltd. (Test) Vs Tramacet® 37.5 mg/325 mg effervescent tablet (Tramadol hydrochloride 37.5 mg and Acetaminophen 325 mg) of Grunenthal GmbH (Reference), in healthy adult human subjects under fasting conditions.

 

Secondary objective:

To monitor the safety and tolerability of the study subjects after administration of Tramadol hydrochloride 37.5 mg and Acetaminophen 325 mg effervescent tablet in healthy adult human subjects under fasting conditions.

24 Subject will be enroll in the study. 

 
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