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CTRI Number  CTRI/2023/05/052878 [Registered on: 18/05/2023] Trial Registered Prospectively
Last Modified On: 29/05/2023
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence study of Doxylamine Succinate 20 mg Pyridoxine HCl 20 mg Extended-Release tablets in healthy adult female subjects under fasting condition 
Scientific Title of Study   An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended-Release) tablets of Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited) in comparison with Bonjesta 20/20 tablets {Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended-Release)} of Duchesnay USA, Inc. in healthy, adult, female subjects under fasting condition. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ICBio/033/0822 Version 00 Dated 27 Aug 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  Ground floor Room no:1 clinical department 16 and 18 ICBio Tower Yelahanka Main Road Chikkabetahalli Vidyaranyapura

Bangalore
KARNATAKA
560097
India 
Phone  9900111997   
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 and 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 and 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  
Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited) Plot no. 29-33, Ancillary, Industrial Area, Deonar, Govandi Mumbai - 400043 INDIA 
 
Primary Sponsor  
Name  Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited) 
Address  Plot no. 29-33, Ancillary, Industrial Area, Deonar, Govandi Mumbai - 400043 INDIA 
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 Priya R   ICBio Clinical Research Pvt Ltd  Clinical department Ground floor, room no:1 #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  Fasting condition 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bonjesta 20/20 tablets {Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended-Release)}  Name of the drug:Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg Route of administration: Oral Frequency: single dose Study duration: 34 days 
Intervention  Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended-Release) tablets  Name of the drug:Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg Route of administration: Oral Frequency: single dose Study duration: 34 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Study subjects should avoid consuming foods/beverages with high vitamin B6 contents from the time of entry to end of treatment visit
2. Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study
3. Willing to be available for the entire study period and to comply with protocol requirements
4. Normal healthy adult female subject of 18 45 years of age
5. Body mass index in the range of 18 30 kg m2 
 
ExclusionCriteria 
Details  1. Any medical or surgical condition which might significantly interfere with the functioning of the gastrointestinal tract or blood forming organs
2. History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past
3. History of severe infection or major surgery in the past 6 months
4. History of Minor surgery or fracture within the past 3 months
5. Significant history or current evidence of malignancy or chronic infectious cardiovascular renal hepatic ophthalmic pulmonary neurological metabolic endocrine hematological gastrointestinal
immunological or psychiatric diseases or organ dysfunction 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-∞   From Day 01 to Day 34
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate Pharmacokinetics parameters Tmax , AUC_%Extrap_obs, λz and t1/2   From Day 01 to Day 34 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   26/05/2023 
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="1"
Days="4" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NONE 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   STUDY TITLE:
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended-Release) tablets of Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited) in comparison with Bonjesta 20/20 tablets {Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended-Release)} of Duchesnay USA, Inc. in healthy, adult, female subjects under fasting condition.

OBJECTIVES:

Primary objective:
To compare the rate and extent of absorption of Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended-Release) tablets of Faromed Lifesciences LLP (Subsidiary of Omnicals Pharma Private Limited) with that of Bonjesta 20/20 tablets {Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended- Release)} of Duchesnay USA, Inc., in healthy, adult, female subjects under fasting condition.
Secondary objective:
To monitor the safety and tolerability of the study subjects after administration of Doxylamine Succinate 20 mg & Pyridoxine HCl 20 mg (Extended-Release)} tablets in healthy, adult, female subjects under fasting condition.

Number of subjects: Thirty two (32)

Duration of clinical study: 34 Days


 
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