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CTRI Number  CTRI/2022/11/046993 [Registered on: 02/11/2022] Trial Registered Prospectively
Last Modified On: 01/11/2022
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioavailability study of Amaryl (glimepiride) Tablet 1 mg in healthy, adult, human subjects under fed condition 
Scientific Title of Study   An Open Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two-Sequence, Two-Period, Crossover Oral relative bioavailability Study of Glimepiride Oral Disintegration Strip 1 mg Distributed by Sanofi Healthcare India Private Limited, India with Amaryl (glimepiride) Tablet 1 mg Manufactured by Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, USA in Healthy, Adult, Human Male Subjects Under Fed Condition. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
21-VIN-0473  Other 
BDR17557, Protocol Version number 01 dated 19 Jan 2022   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Axay Parth  
Designation  Principal Investigator 
Affiliation  Veeda Clinical Research Limited 
Address  Office no. 9 10 and 11 1st 2nd and 3rd Floor Radhe Palladium Panchot

Mahesana
GUJARAT
384205
India 
Phone  7967773000  
Fax    
Email  Axay.P2022@veedacr.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nivedita Telang  
Designation  Head Medical, Foundation 
Affiliation  Veeda Clinical Research Ltd 
Address  Sanofi Healthcare India Private Limited Sanofi House

Mumbai
MAHARASHTRA
400072
India 
Phone  9820185456  
Fax    
Email  Nivedita.Telang@sanofi.com  
 
Details of Contact Person
Public Query  
Name  Bhatia Neha  
Designation  Clinical Project Leader 
Affiliation  Sanofi Healthcare India Private Limited 
Address  Sanofi Healthcare India Private Limited Sanofi House L and T Business Park Saki Vihar Road Powai

Mumbai
MAHARASHTRA
400072
India 
Phone  9769755202  
Fax    
Email  Neha.Bhatia@sanofi.com  
 
Source of Monetary or Material Support  
Sanofi Healthcare India Private Limited, CTS No.117-B, L&T Business Park Saki Vihar Road, Powai, Mumbai:400072 Maharashtra 
 
Primary Sponsor  
Name  Sanofi Healthcare India Private Limited 
Address  Plot Number L 121 Phase III A Verna Industrial Estate Verna-403722 Goa 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 Axay Parth  Veeda Clinical Research Ltd  Office no 9 10 and 11 1st 2nd and 3rd Floor Radhe Palladium Panchot Mehsana Gujarat- 384205, India
Ahmadabad
GUJARAT 		 7967773000

Axay.P2022@veedacr.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ShreenidhiheartandMedicalHospitalEthicsCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy male adult subjects without any disease 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Reference formulation: Amaryl (glimepiride) Tablet 1 mg   Reference formulation: Amaryl (glimepiride) Tablet 1 mg One Tablet will be administered orally at schedule dosing time in sitting posture with 240±2mL of 20% (w/v) glucose solution in water at ambient temperature. 
Intervention  Test Product: Glimepiride Oral Disintegration Strip 1 mg  Glimepiride Oral Disintegration Strip 1 mg One orally disintegrating strip will be administered orally at scheduled dosing time in sitting posture.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1.Healthy, male volunteers of age between 18 and 45 years (both inclusive).
2. Subject weight within normal range according to normal values for Body Mass Index 18.5 to 24.9 kg per m 2 (both inclusive) with minimum of 45 kg weight.
3. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range.
4. Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
5. Subjects having calculated eGFR value at the time of screening ≥ 60 ml per min.
6.Subjects having clinically acceptable chest X-Ray (PA view), if taken.
7. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
8. No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs for the last 06 months.
9.Subjects having negative breath alcohol or urine alcohol test.
10. Subjects willing to adhere to protocol requirements and to provide written informed consent.
11. Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study until 30 days after the last dose of the study medication as judged by the investigator(s), such as (a double barrier method) Condom with spermicide, Condom with diaphragm, or abstinence or subjects should also not donate sperm during this time.
 
 
ExclusionCriteria 
Details  1.Hypersensitivity to Glimepiride or related class of drugs or any of its excipients or heparin.
2.Subjects with intolerance to lactose, fructose or galactose.
3.History or presence of significant cardiovascular, urogenital, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
4. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to dosing of period 01.
5. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood–forming organs etc.
6. Presence of alcoholism or drug abuse.
7. History or presence of smoking (for at least 6 months prior to first drug administration).
8. History or presence of asthma, urticaria or other significant allergic reactions.
9. History or presence of significant gastric and/or duodenal ulceration.
10. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
11. History or presence of cancer or basal or squamous cell carcinoma.
12. Difficulty with donating blood.
13. Subject found positive in Covid-19 RT-PCR test.
14. Difficulty in swallowing solids like tablets or capsules.
15. Any contraindication to blood sampling
16. Use of any prescribed medication or OTC medication including vitamins and herbal remedies during last 30 days prior to dosing in period 01.
17. Major illness within past 3 months.
18. 18. Volunteer who have donated blood (1 unit) or participation in a drug research study within past 90 days prior to the first dose of the study drug.
19. Consumption of xanthine-containing products, tobacco containing products or alcohol or alcoholic products for within 48.00 hours prior to dosing in period 01.
20. Consumption of grapefruit or grapefruit juice containing product within 72 hours prior to dosing in period 01.
21. Positive screening test for any one or more: HIV, HBsAg or Hepatitis C.
22. History or presence of significant easy bruising or bleeding or any other disorder that may cause bleeding.
23. History or presence of significant recent trauma.
24. Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
25. Subject who has clinical signs and symptoms consistent with COVID-19, eg, fever, dry cough, dyspnea, loss of taste and smell, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening. Subject who had severe course of COVID 19 (ie, hospitalization, extracorporeal membrane oxygenation [ECMO], mechanically ventilated).
26. Any vaccination within the last 30 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. Covid-19 vaccine within 30 days before inclusion.

 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary Objective:
To assess the relative bioavailability of Glimepiride Oral Disintegration Strip 1 mg (Test) versus Amaryl® Tablet 1 mg (Reference) after single oral administration under fasting condition.

Primary Pharmacokinetics Parameter:
Cmax, AUC0-t, AUC0-∞ 		 Pre-dose blood sample of 5.0 mL (0.00 hr) will be collected within one hour prior to the dosing.
Post-dose blood samples of 5.0 mL each will be drawn at 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 36.00 hours following drug administration in each period 
 
Secondary Outcome  
Outcome  TimePoints 
• Additional PK parameters for Glimepiride
• Safety assessment of test and reference formulations

Secondary Pharmacokinetics Parameter:
Tmax, AUC_% Extrap_obs, t1/2 and λz  		 Pre-dose blood sample of 5.0 mL (0.00 hr) will be collected within one hour prior to the dosing.

Post-dose blood samples will be drawn at 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 36.00 hours following drug administration in each period.  
 
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)   16/11/2022 
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="0"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is  an Open Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two-Sequence, Two-Period, Crossover Oral bioavailability Study under Fed Condition Condition of Glimepiride Oral Disintegration Strip 1 mg in comparison with Amaryl Tablet 1 mg in 16 healthy male adult subjects that will be conducted at single center in India. The primary outcome assess the relative bioavailability between Glimepiride Orally Disintegrating Strip 1 mg (Test) versus Amaryl Tablet 1 mg (Reference). The secondary outcomes will be to monitor the safety and tolerability after single oral administration under fasting and fed condition of Glimepiride Orally Disintegrating Strip 1 mg (Test) versus Amaryl Tablet 1 mg (Reference). 
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