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CTRI Number  CTRI/2020/12/029980 [Registered on: 22/12/2020] Trial Registered Prospectively
Last Modified On: 18/12/2020
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence Study of Itraconazole Oral Soloution 
Scientific Title of Study   An open label, randomized, balanced, two treatment, two sequence, two period, two way cross-over, single-dose oral bioequivalence study of Itraconazole oral solution (10mg/mL) (T) Manufactured by G.C. Chemie Pharmie Ltd at Kingston Aqua Industries (P) Ltd, Plot No.3, Bhatoli- Kalan, Industrial Town Ship, Baddi with Sporanox (Itraconazole oral solution) (10mg/mL) (R) Authorization holder Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG UK, in normal healthy, adult male subjects under fasting condition. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
S-20-562, Version No.01, dated: 01.08.2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Baby ShaliniS 
Designation  Principal Investigator 
Affiliation  Notrox Research Pvt 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    
Fax    
Email  babyshalini581993@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Baby ShaliniS 
Designation  Principal Investigator 
Affiliation  Notrox Research Pvt Ltd  
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    
Fax    
Email  babyshalini581993@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Baby ShaliniS 
Designation  Principal Investigator 
Affiliation  Notrox Research Pvt Ltd 
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    
Fax    
Email  babyshalini581993@gmail.com  
 
Source of Monetary or Material Support  
G. C Chemie Pharmie limited,5/C, Shree Laxmi Indl.Estte, New Link Road, Andheri (West), Mumbai – 400053, India Tel.: 91-22-26330365; Ext: 362; Mobile.:8657443730 Fax: 91-22-26330506, Website: www.gccpl.com Email: regulatory@gccpl.com  
 
Primary Sponsor  
Name  GC CHEMIE PHARMIE LIMITED 
Address  5/C, Shree Laxmi Industrial Estate, New Link Road, Andheri (West), Mumbai – 400053, India Tel.: 91-22-26330365; Ext: 362; Mobile.:8657443730 Fax: 91-22-26330506, Website: www.gccpl.com Email: regulatory@gccpl.com  
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 
Mr E Sriram M Pharm  NOTROX RESEARCH PVT LTD  No.19/3, second floor, Bikasipura road,Off Kanakapura road,(Behind Metro cash and carry),Bangalore district-560062Karnataka state,India
Bangalore
KARNATAKA 		 9845933077

sriram@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  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy adult subjects between 18-45 years (both inclusive) of age, having a Body Mass Index between 18.50 –24.99 kg/m2(both inclusive), healthy  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Itraconazole Oral Soloution  The recommended dosage of traconazole Oral Solution for oropharyngeal candidiasis is 200 mg (20 mL) daily for 1 to 2 weeks. Clinical signs and symptoms of oropharyngeal candidiasis generally resolve within several days. Route: Oral Duration: 1 to 2 weeks 
Comparator Agent  ITRACONAZOLE ORAL SOLUTION  The recommended dosage of SPORANOX® (itraconazole) Oral Solution for oropharyngeal candidiasis is 200 mg (20 mL) daily for 1 to 2 weeks. Clinical signs and symptoms of oropharyngeal candidiasis generally resolve within several days. Route: Oral Duration: 1 to 2 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  Healthy adult subjects between 18-45 years (both inclusive) of age, having a Body Mass Index between 18.50 –24.99 kg/m2(both inclusive), healthy according to medical history, clinical examination, laboratory evaluations, 12-lead ECGwith chest X-ray (valid for 01 year), haematology, biochemistry, serology (HIV, VDRL/RPR, HepatitisB and C tests), urine analysis will be performed for all subjects. Subjects preferably should be non-smokers and without a history of alcohol or drug abuse 
 
ExclusionCriteria 
Details  Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.History of allergic reaction to heparin.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.Systolic blood pressure less than90 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.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.Pulse rate below60 beats/minute or above 100 beats/minute at the time of screening.Respiratory rate below 15 or above 20 breaths per minute.Oral temperature below 96.2oF or above 99.8 o F at the time of screening.
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.Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-inof each period.An unusual or abnormal diet within 48.00 hours prior to study check-inof each period, whatever reason e.g. because of fasting due to religious reasons.The presence of clinically significant abnormal laboratory values during screening.Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and alcohol breath analysis.A history of difficulty with donating blood or having donated blood in the preceding 90 days prior to the start of the study.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.Positive HIV, VDRL/RPR, Hepatitis B and C tests.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.Prior to check-in of Period-One, complete the Inclusion and Exclusion Criteria Form (Attachment 1 to this protocol) for each volunteer. Only suitable volunteers should be allowed to participate in the study 
 
Method of Generating Random Sequence    
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the rate and extent of absorption of Itraconazole oral solution (10mg/mL) (T) of Manufactured by G.C. Chemie Pharmie Ltd at Kingston Aqua Industries (P) Ltd, Plot No.3, Bhatoli-Kalan,Industrial Town Ship, Baddi with Sporanox(Itraconazole oral solution) (10mg/mL) (R) Authorization holder Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG UK  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the adverse events and to ensure the safety of the subjects following administration of a single dose of Itraconazole oral solution.  2 MONTHS 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/12/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Will be updated after publishing the data 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   An open label, randomized, balanced, two treatment, two sequence, two period, two way cross-over, single-dose oral bioequivalence study of Itraconazole oral solution (10mg/mL) (T) Manufactured by G.C. Chemie Pharmie Ltd at Kingston Aqua Industries (P) Ltd, Plot No.3, Bhatoli- Kalan, Industrial Town Ship, Baddi with Sporanox (Itraconazole oral solution) (10mg/mL) (R) Authorization holder Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG UK, in normal healthy, adult male subjects under fasting condition.

It is a Biequivalence study recommended by CDSCO for subsequent New Drug approval purpose
 
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