CTRI/2024/11/076292 [Registered on: 05/11/2024] Trial Registered Prospectively
Last Modified On:
04/11/2024
Post Graduate Thesis
Yes
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 fasting condition
Scientific Title of Study
An open-label, balanced, randomized, two-treatment, two-sequence, two-period, single dose, crossover relative bioavailability study of Glimepiride Oral Disintegration Strip 1 mg manufactured by: ZIM Laboratories, Nagpur, India, manufactured for: Sanofi Healthcare India Private Limited and Amaryl (Glimepiride) Tablet 1 mg Manufactured by Sanofi-Aventis Deutschland GmbH, Germany in healthy adult human subjects under fasting conditions. (Project Number: AZBE022406, Sponsor Study Code: BDR16756, Version: 1.0, Date: 09-APR-2024).
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
BDR16756 Version 1.0 dated 09-APR-2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr S Sathish Kumar
Designation
Principal Investigtor
Affiliation
Azidus Laboratories Ltd.
Address
Room # 1, clinical department,# 23, School Road,
Rathnamangalam,
Vandalur, Chennai
Chennai TAMIL NADU 600127 India
Phone
919566224183
Fax
Email
ssathishkumar@azidus.com
Details of Contact Person Scientific Query
Name
Dr. S Sathish Kumar
Designation
Principal Investigator
Affiliation
Azidus Laboratories Ltd.
Address
Room # 1, clinical department,# 23, School Road, Rathnamangalam, Vandalur
Chennai TAMIL NADU 600127 India
Phone
9566224183
Fax
Email
ssathishkumar@azidus.com
Details of Contact Person Public Query
Name
Mr. Premnath L
Designation
Head Operations
Affiliation
Azidus Laboratories Ltd
Address
Room # 1, clinical department, # 23, School Road, Rathnamangalam, Vandalur, Chennai –
Chennai TAMIL NADU 600127 India
Phone
8754402346
Fax
Email
prem@azidus.com
Source of Monetary or Material Support
Sanofi Healthcare India Private Limited
Plot Number L-121, Phase-III A, Verna
Industrial Estate, Verna-403722, Goa, India
Primary Sponsor
Name
Sanofi Healthcare India Private Limited
Address
Sanofi House, CTS No. 117-B,L And T Business Park Saki Vihar Road, Powai Mumbai Maharashtra (India) - 400072
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 S Sathish Kumar
Azidus Laboratories Ltd.,
# 23, School Road,
Rathnamangalam,
Vandalur, Chennai – 600127, Chennai TAMIL NADU
91-44-27405244
ssathishkumar@azidus.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Independent Ethics Committee
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
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
Glimepiride Oral Disintegration Strip 1 mg
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
- Healthy male literate volunteers of 18 to 45 years (both years inclusive) with BMI of 18.50 - 24.9 Kg/m2 and with weight minimum of 45 kg.
- Healthy volunteers as evaluated by medical history, vitals and general clinical examination.
- Normal or clinically insignificant biochemical, hematological, urine and serology parameters.
- Non-smokers as evident from the history obtained will be included
- Normal or clinically insignificant ECG.
- Negative urine test for drugs of abuse, alcohol breath analysis.
- Subjects having calculated eGFR value at the time of screening ≥ 60 ml/min – period.
- Volunteers who are willing to use acceptable methods of contraception.
- Volunteers who can give written informed consent and communicate effectively
ExclusionCriteria
Details
- History of any major surgical procedure in the past 03 months.
- Subjects with intolerance to lactose, fructose or galactose.
- History or presence of asthma, urticaria or other significant allergic reactions.
- History or presence of significant recent trauma.
- History or presence of cancer or basal or squamous cell carcinoma.
- Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/ immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant disease as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking the medication.
- History of chronic alcoholism/ chronic smoking/ drug of abuse.
- Volunteers with known hypersensitivity to Glimepiride or any of the excipients.
- History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing
- Volunteer who are positive for hepatitis B surface antigen, anti-hepatitis C antibody, treponemal antibodies and human immunodeficiency virus (HIV1&2) antibodies.
- Present or past history of intake of drugs or any prescription drug or over the counter (OTC) drugs within 14 days which potentially modify kinetics / dynamics of Glimepiride or any other medication judged to be clinically significant by the investigator.
- History of consumption of grapefruit and/or its products within 10 days prior to the start of study.
- Volunteer who had participated in any other clinical study or who had bled during the last 03 months before check-in.
- History of consumption of one or more of the below, 48 hours prior to dosing:
- Xanthine containing food or drinks such as cola, chocolate, coffee or tea, citrus fruits or items (lime, lemon and orange), alcohol and any other food/beverage known to have interactions as deemed by the investigator.
- Volunteers who are dysphagic
Method of Generating Random Sequence
Stratified block randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To assess the relative bioavailability of Glimepiride Oral
Disintegration Strip 1 mg (Test) versus Amaryl Tablet 1 mg
(Comparator) after single oral administration under fasting
conditions.
Secondary objective:
- Additional PK parameters for Glimepiride
- Safety assessment of test and comparator formulations
Secondary PK parameters: Tmax, T1/2 (terminal half-life), Kel and AUC_%Extrap_obs .
Time Points: 00.00 (Pre-dose), 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 24.00, and 36.00 hours post dose
Target Sample Size
Total Sample Size="14" Sample Size from India="14" 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)
29/11/2024
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
N/A
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, two-treatment, two-sequence, two-period, single dose,
crossover relative bioavailability study of Glimepiride Oral Disintegration
Strip 1 mg manufactured by: ZIM Laboratories, Nagpur, India, manufactured for:
Sanofi Healthcare India Private Limited and Amaryl® (Glimepiride) Tablet 1 mg
Manufactured by Sanofi-Aventis Deutschland GmbH, Germany in healthy adult human
subjects under fasting conditions that will be conducted at single center in
India. The primary outcome is to 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).