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CTRI Number  CTRI/2020/08/027430 [Registered on: 27/08/2020] Trial Registered Prospectively
Last Modified On: 23/11/2020
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence study of S Metoprolol and Telmisartan Modified Release Tablets (25 mg 40 mg)with Metpure XL 25 S Metoprolol Succinate Prolonged release tablets and Telma 40 (Telmisartan Tablets IP 40 mg) in healthy adult human subjects under fasting conditions 
Scientific Title of Study   A randomized, open label, balanced, two-treatment, two-period, two-sequence, single oral dose, cross-over, bioequivalence study comparing S(-)Metoprolol and Telmisartan Modified Release Tablets (25 mg + 40 mg) of Emcure Pharmaceuticals Ltd, India with Metpure-XL® 25 [S(-) Metoprolol Succinate Prolonged release tablets] manufactured by Emcure Pharmaceuticals Ltd, India and Telma®40 (Telmisartan Tablets I.P. 40 mg) manufactured by Glenmark Pharmaceuticals Ltd, India in healthy adult human subjects under fasting condition. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BIOS-2019-081, version 01, 03 Mar 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jagdip Upadhyaya 
Designation  Principal Investigator 
Affiliation  Bio Scientific Research Laboratories (I) Pvt Ltd 
Address  BIOS HOUSE, Plot No 106/3, Aries Compound, Opp Thakur Mall, SV Road, Mira Road, Thane 401104

Thane
MAHARASHTRA
401104
India 
Phone  022-28963582  
Fax    
Email  info@biosrl.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jagdip Upadhyaya 
Designation  Principal Investigator 
Affiliation  Bio Scientific Research Laboratories (I) Pvt Ltd 
Address  BIOS HOUSE, Plot No 106/3, Aries Compound, Opp Thakur Mall, SV Road, Mira Road, Thane 401104

Thane
MAHARASHTRA
401104
India 
Phone  022-28963582  
Fax    
Email  info@biosrl.com  
 
Details of Contact Person
Public Query  
Name  Tarak Desai 
Designation  Manager Clinical Research 
Affiliation  Emcure Pharmaceuticals Limited 
Address  Emcure Pharmaceuticals Limited, R&D Centre, Uvarsad Cross Road, Sarkhej-Gandhinagar Highway, Adalaj, Dist: Gandhinagar, India - 382421

Gandhinagar
GUJARAT
382421
India 
Phone  07930640179  
Fax    
Email  tarak.desai@emcure.co.in  
 
Source of Monetary or Material Support  
Emcure Pharmaceuticals Ltd Plot No P1 & P2, ITBT Park, M1DC, Phase II, Hinjwadi, Pune 411057,India 
 
Primary Sponsor  
Name  Emcure Pharmaceuticals Ltd 
Address  Plot No P1 & P2, ITBT Park, M1DC, Phase II, Hinjwadi, Pune 411057,India 
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 Jagdip Upadhyay  Bio Scientific Research Laboratories I Pvt Ltd  BIOS HOUSE, Plot No. 106/3, Aries Compound, Opp. Thakur Mall, SV Road, Mira Road, Thane 401104.
Thane
MAHARASHTRA 		 02228963582

info@biosrl.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ashirwad Ethics Committee (AEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adult human subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Metpure - XL 25 S - Metoprolol Succinate Prolonged-release 25 mg tablets  Each Prolonged-release film coated tablet contains 23.75 mg of S- Metoprolol Succinate equivalent to 25 mg of S- Metoprolol Tartrate (Single dose) duration of therapy: one day 
Intervention  S- Metoprolol and Telmisartan Modified Release Tablets 25 mg,40 mg  Each Modified release tablet contains 25 mg,40 mg of S- Metoprolol and Telmisartan Modified Release Tablets (Single dose) duration of therapy:one day 
Comparator Agent  Telma 40 Telmisartan Tablets I.P 40 mg  Each tablet contains 40 mg of Telmisartan (Single dose) duration of therapy:one day 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Subjects willing to give Informed Consent.
2. Healthy adult human subjects within 18-45 years of age (inclusive).
3. Subject with Body Mass Index (BMI) having range between 18.0 and 25.0 (both inclusive), calculated as weight in Kg and height in m2.
4. Willingness to follow protocol requirements as per the subject information sheet.
5. Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study.
6. Subjects whose screening laboratory values are within normal limits or considered by the Physician / Principal Investigator / Co-Investigator to be of no clinical significance.
7. Physical examination and vital sign examination of the subject conducted on the day of screening and check-in are within acceptable limits.
8. Subjects who agree to abstain from consuming any xanthine / caffeine containing food or beverages (chocolates, tea, coffee or cola drinks), grapefruit juice and products, alcoholic products, cigarettes and tobacco products for at least 48.00 hours prior to dosing and throughout the study period until the last blood sample is being obtained. 
 
ExclusionCriteria 
Details  Subjects will be excluded for ANY ONE of the following reasons:
1. Any known contra-indication to Telmisartan, S (-) Metoprolol or related class of drugs.
2. Significant medical disorder (cardiovascular, gastrointestinal, renal, pulmonary, haematological, endocrine, or metabolic disorder (e.g. diabetes mellitus), malignancy, or immunodeficiency disorder, hepatic and neurological or psychiatric) as determined by history.
3. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood–forming organs etc.
4. Significant abnormal finding as determined by clinical examination including ECG and vital signs.
5. Difficulty in withdrawing the blood.
6. Difficulty in swallowing the tablet.
7. Found positive in urine test for drugs of abuse done before check-in for each study period.
8. Found positive in breath alcohol test done before check-in for each study period.
9. Depot injections or implants within 6 months.
10. Positive screening test for any one: HIV, hepatitis B, hepatitis C and VDRL.
11. Consumption of xanthine / caffeine containing products, tobacco containing products, grapefruit juice and products and alcohol within 48.00 hours prior to dosing.
12. Refusal to abstain from food from at least 10.00 hours prior to study drug administration until at least 04.00 hours post-dose, in each study period.
13. Refusal to abstain from consumption of tobacco products 48.00 hours prior to dosing until the last blood sample collection of last study period.
14. Refusal to abstain from fluid from at least 01.00 hour prior to study drug administration until at least 02.00 hours post-dose, in each study period except about 240 ± 02 mL of water given
during administration of study drug.
15. Requirement of any medication for chronic illness.
16. Consumption of any medication (prescribed or OTC) during 21 days prior to dosing and till the end of the study.
17. Subject has a history of allergic response to foods, which are being used in the study meal.
18. Participation in any clinical study during 90 days prior to administration of study medication.
19. Blood donation during 90 days prior to administration of study medication.
20. Clinically significant illness within 4 weeks before start of study.
21. Criteria for blood pressure and pulse:
- Systolic blood pressure below 100 mm of Hg or above 140 mm of Hg.
- Diastolic blood pressure below 60 mm of Hg or above 90 mm of Hg. Minor deviation (2-4 mm
of Hg) at check-in may be acceptable at the discretion of the physician / investigator.
- Pulse rate below 60/ minute or above 100/ minute.
22. Subjects with any condition, which in the opinion of the investigators makes the subject
unsuitable for inclusion. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy: To assess the bioequivalence between Test product: S (-) Metoprolol and Telmisartan Modified Release Tablets (25 mg + 40 mg) with Reference product: Metpure - XL® 25 [S (-) Metoprolol Succinate Prolonged-release tablets] and Telma® 40 (Telmisartan Tablets I.P 40 mg)

Safety: To monitor the safety and tolerability of healthy adult human subjects. 		 Blood samples will be withdrawn at predose and 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 14.00, 18.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00 hours post-dose. 
 
Secondary Outcome  
Outcome  TimePoints 
Safety: To monitor the safety and tolerability of healthy adult human subjects.  Vital signs examination will be done at the time of recruitment, prior to dosing and at 03.00, 06.00,
12.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00 hours after administration of the study drug. 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   01/09/2020 
Date of Study Completion (India) 30/09/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="17" 
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
Modification(s)  
A randomized, open-label, balanced, two-treatment, two-period, twosequence, single oral dose, cross-over bioequivalence study in healthy adult human subjects under fasting conditions.
Efficacy: To assess the bioequivalence between Test product: S (-) Metoprolol and Telmisartan Modified Release Tablets (25 mg + 40 mg) of Emcure Pharmaceuticals Ltd, India and Reference products: Metpure - XL® 25 [S (-)
Metoprolol Succinate Prolonged-release tablets] manufactured by Emcure Pharmaceuticals Ltd., India and Telma® 40 (Telmisartan Tablets I.P 40 mg) manufactured by Glenmark Pharmaceuticals Ltd., India under fasting conditions in healthy adult human subjects in a randomized crossover study.
Safety: To monitor the safety and tolerability of healthy adult human subjects.
Total 34 healthy adult human subjects who meet all inclusion and exclusion criteria will be recruited. In each of the study periods, following an overnight fast of at least 10.00 hours, a single oral dose of S (-) Metoprolol and Telmisartan Modified Release Tablets (25 mg + 40 mg) of Emcure Pharmaceuticals Ltd, India i.e. one tablet of test product or one tablet of each reference products- Metpure - XL® 25 [S (- ) Metoprolol Succinate Prolonged-release tablets] manufactured by Emcure Pharmaceuticals Ltd., India and Telma® 40 (Telmisartan Tablets I.P 40 mg) manufactured by Glenmark Pharmaceuticals Ltd., India will be orally administered to each subject as per the randomization schedule in each period with about 240 ± 02 mL of drinking water at ambient temperature under fasting conditions in sitting position.
 
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