CTRI/2023/01/048758 [Registered on: 05/01/2023] Trial Registered Prospectively
Last Modified On:
10/10/2024
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
Bioequivalence study of Trelagliptin 100 mg Tablets in healthy adult human subjects.
Scientific Title of Study
An open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, truncated, crossover oral bioequivalence study between the Test Product, Trelagliptin 100 mg Tablets (Zuventus Healthcare Ltd., India) and the Reference Product, Zafatek® (Trelagliptin 100 mg) tablets (Takeda Pharmaceutical Company Limited, Japan) in healthy, adult, human subjects under fasting conditions.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
AR026-22, (Ver. No. 01 dated: 07 July 2022)
Protocol Number
BE/ND/30/2022
DCGI
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Bhupesh Dewan
Designation
Director, Medical Services
Affiliation
Zuventus Healthcare Limited
Address
Department of Medical Services, Zuventus Healthcare Ltd., Zuventus House, Plot Y2, CTS No.: 358/A2, Near Nahur Railway Station, Nahur (W), Mumbai
Mumbai MAHARASHTRA 400078 India
Phone
Fax
Email
bhupesh.dewan@zuventus.com
Details of Contact Person Scientific Query
Name
Dr Bhupesh Dewan
Designation
Director, Medical Services
Affiliation
Zuventus Healthcare Limited
Address
Department of Medical Services, Zuventus Healthcare Ltd., Zuventus House, Plot Y2, CTS No.: 358/A2, Near Nahur Railway Station, Nahur (W), Mumbai
Mumbai MAHARASHTRA 400078 India
Phone
Fax
Email
bhupesh.dewan@zuventus.com
Details of Contact Person Public Query
Name
Dr Bhupesh Dewan
Designation
Director, Medical Services
Affiliation
Zuventus Healthcare Limited
Address
Department of Medical Services, Zuventus Healthcare Ltd., Zuventus House, Plot Y2, CTS No.: 358/A2, Near Nahur Railway Station, Nahur (W), Mumbai
3rd and 4th Floors, Archies Continental, P. No. 2A, 3, S. No. 1094 and 1095, Adj to Kukatpally Metro station, Kukatpally, Hyderabad 500072 Hyderabad TELANGANA
040-69089999
jyothi.kotha@advityresearch.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Vasavi Institutional Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy adult human subjects under fasting conditions
Zafatek® (Trelagliptin 100 mg) tablets (Takeda Pharmaceutical Company Limited, Japan)
1 tablet as a single oral dose
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
1. Healthy human subjects between 18-45 years of age (including both)
2. Subjects able to communicate effectively.
3. HbA1c levels (As per lab reference ranges including both normal and prediabetic individuals).
4. Volunteers who give consent by signing the informed consent form after understanding the study-related information about the nature, risk, and scope of the clinical study as well as the expected adverse effects of the drug.
5. Volunteers who are non-smokers will be included in the study.
6. Body mass index in the range of 18.5 to 29.9 kg/m² (weight should be ≥ 50 Kg).
7. Normal 12-lead ECG
8. Normal chest X-ray
9. Normal laboratory parameters
10. Absence of disease markers of HIV 1 & 2, hepatitis B & C virus and VDRL
11. Subject willing to abstain from all kinds of alcoholic beverages, pan or pan masala, gutkha, masala (containing betel nut), having caffeine/xanthine containing foods or beverages and grapefruit or citrus containing foods or juices from at least 48.00 hours prior to admission until the last blood sample collection in each study period.
12. Female subjects:
• of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD) or abstinence.
• Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
ExclusionCriteria
Details
1. Volunteers having contraindication or hypersensitivity (e.g., anaphylaxis) to Trelagliptin or related class of drugs and any of its ingredients.
2. History or presence of significant seizures, diabetes, migraine, hypertension, cardiovascular, pulmonary, neurological or psychiatric disease/disorder, dermatological, endocrine, immunological, hepatic, renal, hematopoietic, gastrointestinal, ongoing infectious diseases, or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician.
3. History or evidence of Lactic Acidosis.
4. History or evidence of Hypoglycemia/recurrent hypoglycemic attacks.
5. History of insulin dependent diabetes.
6. History or evidence of exfoliative dermatitis, Stevens - Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).
7. Any known enzyme inducing or inhibiting drug taken within 14 days before each study period.
8. Participation in a drug research study within 90 days prior to dosing of this study.
9. Blood loss (more than 100 ml) or whole blood donation within 90 days prior to drug administration.
10. A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
11. History of addiction to any recreational drug or drug dependence.
12. An unusual or abnormal diet, for whatever reason within 48.00 hours prior to admission of each period, e.g., fasting due to religious reasons.
13. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study admission of each period.
14. Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids and barbiturates) in urine during the admission of each study period.
15. Positive results for alcohol consumption during the admission of each study period.
16. History of pre-existing bleeding disorder.
17. Difficulty with donating blood.
18. Difficulty in swallowing oral solid investigational products.
19. Blood pressure on the day of admission of each study period
a. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
b. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
20. Pulse rate less than 60 beats/minute or more than 100 beats/minute on the day of admission of each study period.
21. Use of any prescribed medication or OTC medicinal products including vitamins and herbal drugs within the 2 weeks prior to commencement of the study or at least 5 half-lives of the compound whichever period is longer prior to study admission.
22. History of alcohol abuse and/or dependence within six months of the screening visit or History of drug abuse or use of illegal drugs within 90 days prior to dosing of this study.
23. Females Subjects:
➢ Female subjects demonstrating a positive serum pregnancy test.
➢ Female volunteer who is pregnant or currently breast-feeding.
➢ Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to
study or used hormonal contraceptives within 14 days before dosing.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To demonstrate the bioequivalence between Trelagliptin 100 mg Tablets (Zuventus Healthcare Ltd., India) and the Reference Product, Zafatek® (Trelagliptin 100mg) tablets (Takeda Pharmaceutical Company Limited, Japan) in healthy, adult, human subjects under fasting conditions.
Pharmacokinetic parameters Cmax, AUC0-72 for Trelagliptin from the test product to that of reference products will be assessed on pre-dose (00.00 hour) and at 00.17, 00.33, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose in each study period.
Secondary Outcome
Outcome
TimePoints
To monitor the safety, tolerability of single dose of Trelagliptin 100 mg tablets.
Admission in the study to last study sample collection
Target Sample Size
Total Sample Size="32" Sample Size from India="32" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="32"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Trelagliptin
is an oral long-acting dipeptidyl peptidaseâ€4 (DPPâ€4) inhibitor with
onceâ€weekly dosing in type 2 Diabetes Mellitus (T2DM). This study is designed
to evaluate the bioequivalence between the Test product, Trelagliptin 100 mg
tablets of Zuventus Healthcare Limited, India and the Reference product, Zafatek®
(Trelagliptin 100mg) tablets of Takeda Pharmaceutical Company Limited, Japan in
healthy, adult, human subjects under fasting conditions