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
- Conditions
- Adult human subjects
- Registration Number
- CTRI/2020/08/027430
- Lead Sponsor
- Emcure Pharmaceuticals Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 34
- Subjects willing to give Informed Consent.
- Healthy adult human subjects within 18-45 years of age (inclusive).
- 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.
- Willingness to follow protocol requirements as per the subject information sheet.
- 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.
- Subjects whose screening laboratory values are within normal limits or considered by the Physician / Principal Investigator / Co-Investigator to be of no clinical significance.
- Physical examination and vital sign examination of the subject conducted on the day of screening and check-in are within acceptable limits.
- 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.
- 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.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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) 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. 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 Measures
Name Time Method 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,
Trial Locations
- Locations (1)
Bio Scientific Research Laboratories I Pvt Ltd
🇮🇳Thane, MAHARASHTRA, India
Bio Scientific Research Laboratories I Pvt Ltd🇮🇳Thane, MAHARASHTRA, IndiaDr Jagdip UpadhyayPrincipal investigator02228963582info@biosrl.com