The Bioequivalence Study of Linagliptin 5 mg Film-coated Tablet in Healthy Thai Volunteers

NCT06243809 | Unknown Phase 1

• 1 other identifier: BE23-034
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Linagliptin 5 mg Film-coated Tablet (LINIPTIN) and Reference Product (Trajenta®) in Healthy Thai Volunteers under Fasting Conditions

Conditions

Healthy Volunteer

Keywords

Linagliptin

Outcome Measures

Primary Outcomes (2)

• Plasma Area Under the Curve (AUC(0 to 72hr)) for Linagliptin

  Plasma Area Under the Curve of Linagliptin

  Through 72 Hours Post Dose

• Peak Plasma Concentration (Cmax) of Linagliptin

  Peak Plasma Concentration (Cmax) of Linagliptin

  72 Hours Post Dose

Study Arms (2)

Linagliptin 5 mg, Then Trajenta 5 mg

EXPERIMENTAL

Participants first received Linagliptin 5 mg tablet 1 tablet (Test product) in a fasting state. After a washout period of 1 week, they then received Trajecta 5 mg tablet (Reference product) in a fasting state.

Drug: Linagliptin 5 mg Oral Tablet; Drug: Trajenta 5 MG Oral Tablet

Trajenta 5 mg, Then Linagliptin 5 mg

ACTIVE COMPARATOR

Participants first received Trajenta 5 mg tablet 1 tablet (Reference product) in a fasting state. After a washout period of 1 week, they then recieved Linagliptin 5 mg tablet (Test product) in a fasting state

Drug: Linagliptin 5 mg Oral Tablet; Drug: Trajenta 5 MG Oral Tablet

Interventions

Linagliptin 5 mg Oral Tablet DRUG

Linagliptin 5 mg Oral Tablet

Also known as: Linagliptin

Linagliptin 5 mg, Then Trajenta 5 mg; Trajenta 5 mg, Then Linagliptin 5 mg

Trajenta 5 MG Oral Tablet DRUG

Linagliptin 5 mg Oral Tablet (Trajenta )

Also known as: Linagliptin

Linagliptin 5 mg, Then Trajenta 5 mg; Trajenta 5 mg, Then Linagliptin 5 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Thai male subjects between the ages of 18 to 55 years
• Body mass index between 18.5 to 30.0 kg/m2
• Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study.
• Non-pregnant woman (negative pregnancy test) and not currently breast feeding
• Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to check-in in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to check-in in Period 1 until 14 days after the end of study in Period 2. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1:
• Postmenopausal for at least 1 year or
• Surgically sterile (bilateral tubal ligation, bilateral oophorectomy orhysterectomy) at least 6 months
• Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 14 days after the end of study in Period 2.
• Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study

You may not qualify if:

• History of allergic reaction or hypersensitivity to linagliptin or to any of the excipients
• History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hypo-/hyperthyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper-/hypotension), psychiatric, neurologic (e.g. seizures), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
• Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19
• History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period
• History or evidence of type 1 diabetes mellitus, diabetic ketoacidosis
• History or evidence of acute pancreatitis
• History or evidence of severe infection or severe accident within 14 days prior to check-in in each period
• History or evidence of severe joint pain
• History or evidence of bullous pemphigoid
• History of problems with swallowing tablet or capsule
• History of sensitivity to heparin or heparin-induced thrombocytopenia
• Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
• History of diarrhea, dehydration or vomiting within 24 hours prior to check-in in each period
• History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
• lead ECG demonstrating QTc \>450 msec, a QRS interval \>120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject's eligibility.

Sponsors & Collaborators

• International Bio service: lead

MeSH Terms

Interventions

Linagliptin; Tablets

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Uthai Suvanakoot

  International Bio service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nannapat Wannaphruek

CONTACT

024415211; nannapat.wan@mahidol.ac.th

Thanaporn Wongyai

CONTACT

024415211; thanaporn.won@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 6, 2024
• Study Start: April 24, 2024
• Primary Completion: May 10, 2024
• Study Completion: July 2, 2024
• Last Updated: February 7, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share