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CTRI Number  CTRI/2025/11/097768 [Registered on: 20/11/2025] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   An Open Label Single Dose Two Period Oral Bioequivalence Study Comparing Guaifenesin And Dextromethorphan Hydrobromide Extended Release Tablets 1200 mg/ 60 mg In Healthy Adult Human Subjects Under Fed Conditions 
Scientific Title of Study   An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Bioequivalence Study Comparing Guaifenesin And Dextromethorphan Hydrobromide Extended Release Tablets 1200 mg/ 60 mg Manufactured By Marksans Pharma Ltd Plot No L 82 L83 Verna Industrial Estate Verna Goa 403722 With Mucinex DM 1200 mg Guaifenesin and 60 mg Dextromethorphan HBr Extended Release Bi layer Tablets Distributed By RB Health US Parsippany NJ 07054 0224 In Healthy Adult Human Subjects Under Fed Conditions 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SLS-BE-0097-25-GUAI Version No: 01 Date: 30 Sep 25  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pradeep T 
Designation  Principal Investigator  
Affiliation  Spinos Lifescience and research private limited 
Address  Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore

Coimbatore
TAMIL NADU
641029
India 
Phone  08220586899  
Fax    
Email  pradeep.t@spinoslifescience.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradeep T 
Designation  Principal Investigator  
Affiliation  Spinos Lifescience and research private limited 
Address  Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore


TAMIL NADU
641029
India 
Phone  08220586899  
Fax    
Email  pradeep.t@spinoslifescience.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep T 
Designation  Principal Investigator  
Affiliation  Spinos Lifescience and research private limited 
Address  Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore


TAMIL NADU
641029
India 
Phone  08220586899  
Fax    
Email  pradeep.t@spinoslifescience.com  
 
Source of Monetary or Material Support  
Marksans Pharma Limited D185 and D186 TTC Industrial Area MIDC Shiravane Nerul Navi Mumbai 400706  
 
Primary Sponsor  
Name  Marksans Pharma Limited  
Address  D185 and D186 TTC Industrial Area MIDC Shiravane Nerul Navi Mumbai 400706  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Spinos Life Science and Research Private limited  29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore 641029 Tamil Nadu India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pradeep T  Spinos Lifescience and Research private limited  Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
Coimbatore
TAMIL NADU 		 08220586899

pradeep.t@spinoslifescience.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Committe ECR/84/lndt/TN/2013/RR-24  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  fed conditions 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Guaifenesin And Dextromethorphan Hydrobromide Extended Release Tablets 1200 mg/ 60 mg Manufactured By Marksans Pharma Ltd Plot No L82 L83 Verna Industrial Estate Verna Goa 403722   A Single oral dose of Guaifenesin And Dextromethorphan Hydrobromide Extended Release Tablets 1200 mg/ 60 mg will be administered in each period Total Duration is 12 Days  
Comparator Agent  Mucinex DM 1200 mg Guaifenesin and 60 mg Dextromethorphan HBr Extended Release Bi layer Tablets Distributed By RB Health US Parsippany NJ 07054-0224  A Single oral dose of GMucinex DM 1200 mg Guaifenesin and 60 mg Dextromethorphan HBr Extended Release Bi layer Tablets will be administered in each period Total Duration is 12 Days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Normal healthy adult human subjects of age between 18 to 45 years and Body Mass Index BMI ranges between 18.50 kg/m2 to 29.99 kg/m2
Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in
Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance
Healthy as documented by the medical history physical examination including but may not be limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments
Generally healthy as documented by 12-lead electrocardiogram ECG Chest X-Ray and clinical laboratory assessments
Willing to consume non vegetarian diet
Willing to comply to all requirements of this study protocol as well as instructed by the study personnel
Non smokers
Generally healthy as documented by gynaecological examination and breast examination for female subjects period I only
Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to initiation of the study & a negative urine pregnancy test prior to check-in of each period
If subject is female currently not pregnant not lactating or not attempting to become pregnant for 4 weeks before the screening visit throughout the duration of the study and 3 weeks after the subject’s last study related visit for eligible subjects only if applicable has a negative serum pregnancy test and is of
1 year post menopausal no menstrual period for at least 12 consecutive months without any other medical cause
Surgically sterile bilateral tubal ligation bilateral oophorectomy or hysterectomy
or is of
childbearing potential willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study
double barrier methods condoms cervical cap diaphragm and vaginal contraceptive film with spermicide
intrauterine device IUD with a low failure rate of less than 1 percentage per year
or is of
childbearing potential and not sexually active willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study in the event the subject becomes sexually active  
 
ExclusionCriteria 
Details  Evidence of allergy or known hypersensitivity to Guaifenesin And Dextromethorphan HBr or its inactive ingredients
Allergic reaction symptoms may include trouble breathing rash itching and swelling of your face lips tongue or throat
Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease
Any major illness in the last three months or any significant ongoing chronic medical illness
Renal or liver impairment
Any disease or condition which might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system Or any other body system presence of Diabetes Mellitus and Psychosis
History of alcohol addiction or abuse
Consumption of caffeine and or Xanthine containing products ie coffee tea chocolate and caffeine-containing sodas colas etc cigarettes and tobacco containing products for at least 48.00 hours prior to check in and throughout the entire study
Consumption of alcohol and its products grapefruit and/ or its juice and poppy containing foods within 48.00 hours prior to clinic admission and throughout the entire study
Subjects who have taken any prescription medications within 14 days prior to study check-in and throughout the study and any over the counter medicinal products herbal medications within 07 days prior to study check-in and throughout the study
Subjects who have taken an unusual diet for whatever reason eg low salt for 48.00 hours prior to dosing and throughout the study
Subject who had participated in any other study within the 90 days of check-in
History of difficulty in swallowing
History of difficulty in accessibility of veins
Positive results for urine screen of drugs of abuse Marijuana THC amphetamine AMP barbiturates BAR cocaine COC benzodiazepines BZD and morphine MOR in urine prior to check in of each period
Positive results for alcohol test prior to check-in of each period
Any blood donation / excess blood loss within 90 days of check-in
Ingestion of any hormonal agent at any time within 14 days prior to start of study check-in
Use of hormone replacement therapy for a Period of 06 months prior to dosing
Female subjects demonstrating a positive pregnancy screen
Female subjects who are currently lactating
Females likely to become pregnant during conduction of the study  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the Bioequivalence of Guaifenesin And Dextromethorphan Hydrobromide Extended Release Tablets 1200 mg/ 60 mg Manufactured By Marksans Pharma Ltd Plot No L 82 L 83 Verna Industrial Estate Verna Goa 403722 With Mucinex DM 1200 mg Guaifenesin and 60 mg Dextromethorphan HBr Extended Release Bi layer Tablets Distributed By RB Health US Parsippany NJ 07054 0224 In Healthy Adult Human Subjects under Fed  27 Time points
00.00 Hrs 00.17 Hrs 00.33 Hrs 00.50 Hrs 00.67 Hrs 00.83 Hrs 01.00 Hrs 01.33 Hrs 01.67 Hrs 02.00 Hrs
02.50 Hrs 03.00 Hrs 04.00 Hrs 04.50 Hrs 05.00 Hrs 06.00 Hrs 06.25 Hrs 06.50 Hrs 06.75 Hrs 07.00 Hrs 08.00 Hrs 10.00 Hrs 12.00 Hrs 16.00 Hrs 24.00 Hrs 48.00 Hrs 72.00 Hrs 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety and tolerability of test product comparing with the reference product in healthy adult human subjects under fed conditions  27 Time points
00.00 Hrs 00.17 Hrs 00.33 Hrs 00.50 Hrs 00.67 Hrs 00.83 Hrs 01.00 Hrs 01.33 Hrs 01.67 Hrs 02.00 Hrs
02.50 Hrs 03.00 Hrs 04.00 Hrs 04.50 Hrs 05.00 Hrs 06.00 Hrs 06.25 Hrs 06.50 Hrs 06.75 Hrs 07.00 Hrs 08.00 Hrs 10.00 Hrs 12.00 Hrs 16.00 Hrs 24.00 Hrs 48.00 Hrs 72.00 Hrs 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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)   05/12/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

At least 16 number of healthy adult human subjects 12 Male + 4 Female  will be recruited to evaluate the bioequivalence of Test product with the Reference product

As per the discretion of the Investigator a sufficient number of stand-by subjects will be included additionally to ensure successful dosing of 16 subjects in period I alone
In each period subjects will be housed in the clinical facility for at least 11.00 hours pre dose to 72.00 hours post dose
A washout period of at least 07 days will be maintained between each dosing period
In each period after an overnight fasting of at least 10.00 hours in the morning high-fat, high-calorie non veg breakfast will be provided 30 minutes before dosing
After consumption of high-fat, high-calorie non veg breakfast in the Morning a single oral dose of either the test product T or reference product R will be administered as per the randomization schedule with 240 mL of drinking water at ambient temperature
Blood pressure radial pulse rate body temperature and wellbeing status will be enquired and recorded at pre-dose 00.00 hour within 75 minutes of before dosing and at 01.00, 03.00, 06.00, 12.00, 24.00 and 48.00 hours ± 60 minutes post dose
Physical examination and vitals will be recorded before check in check out 72 hours for each period and at any time if necessary
 
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