A Bioequivalence study of a randomized, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Linagliptin Film Coated Tablets 5 mg relative to Trajenta 5 mg film-coated tablets in healthy Thai adult volunteers under fasting conditio
- Conditions
- Healthy subjectsBioequivalence (Linagliptin) 5 mg
- Registration Number
- TCTR20221212003
- Lead Sponsor
- Mylan Laboratories Limited.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- nknown
- Sex
- All
- Target Recruitment
- 36
1. Age18 to 55 years Subject must meet age requirements at the time of signing the initial informed consent and the initial study medication administration.
2.Sex Males and or non-pregnant non-lactating females.
a. Women of childbearing potential must have a negative urine human chorionic gonadotropin pregnancy test performed on screening day and prior to the initial dose of each period of study medication.
b. Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history
postmenopausal with spontaneous amenorrhea for at least one year
bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months or
total hysterectomy and an absence of bleeding for at least 3 months.
3.Weight
Each subject is required to have a Body Mass Index value less than or equal to 30.0 but greater than or equal to 18.5. All weight values are to be reported according to the scale precision (example the nearest tenth, 72.3 kg). The subject height is to be reported in centimeters to the nearest tenth. Each subject BMI is to be calculated using the reported weight in kilograms and height in centimeters and it is to be reported to the nearest tenth (26.3).
4.Smoking Status Moderate smokers (up to 10 cigarettes or equivalent per day refer to Appendix 7 Nicotine Equivalence Estimates) are permitted.
Documentation of smoking status is to be via the questionnaire in Appendix 6, with results included in the study database (if applicable), and Subject CRF.
5.Adequate venous access in both arms for the collection of a number of blood samples during the study.
6.Able to understand and sign the written Informed Consent Form.
6.1Utilization of illiterate subjects is permitted when performed according to GCP as well as regulations guidances for the region of submission and country of conductance.
7.Willing to follow the protocol requirements and comply with protocol restrictions and allow investigators to draw approximately 7 mL of blood for monitoring subject safety after the completion of the study.
8.All subjects should be judged by the Principal Investigator or Medical Sub-Investigator as normal and healthy during a pre-study medical evaluation performed within 28 days of the initial dose of study medication and the second screening to confirm the volunteers eligibility before participating to period II of the study which will include
1.Institutionalized subjects.
2.Social Habits:
a.Consumption of any alcoholic beverage within the 48 hours prior to the initial administration of study medication and until the completion of each period of the study.
b.Consumption of any caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial administration of study medication and until the completion of each period of the study.
c.Any recent, significant change in dietary or abnormal diet within 48.0 hours prior to study check-in.
d.History of drug and/or alcohol abuse within one year of start of study.
e.Use of any nicotine containing product within the 48 hours prior to the initial administration of study medication until the completion of each period of the study.
3.Medications
a.Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial administration of study medication and until the completion of each period of the study.
b.A depot injection or implant of any drug within 3 months prior to initial administration of study medication.
c.Use of any medication, herbal supplement, or vitamin known to induce or inhibit hepatic enzyme activity within 14 days prior to the initial administration of study medication and until the completion of each period of the study.
4.Diseases:
a.History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease or malignancies unless deemed not clinically significant by the Principal Investigator or Medical Sub-Investigator.
b.History of tuberculosis.
c.History of difficulties in swallowing, or any gastrointestinal disease (i.e. cholecystectomy) or previous GI surgery other than appendectomy which could affect drug absorption. History of gastrointestinal obstruction, particularly paralytic ileus.
d.Acute illness at the time of either the pre-study medical evaluation or dosing period I.
5.Any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the subject from safely participating in the study.
6.Intolerance to venipuncture.
7.Donation or loss of blood or plasma: 50 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication.
8.Allergy or hypersensitivity to Linagliptin, other related products, or any inactive ingredients.
9.Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
10.Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Medical Sub-Investigator, could contraindicate the subject participation in this study.
11.Subject with B.P. is Systolic B.P < 90, >=140 mm/Hg, Diastolic B.P < 60, >=90 mm/Hg or pulse rate > 100 beats per minute.
12.Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).
13.Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).
14.Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).
15.Participation in any clinical study within the past 3 months before the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax, AUC0-72 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.17, 1.33, 1.50, 1.67, 1.83, 2.00, 2.50, 3.00, 3.50, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours Pharmacokinetic parameters
- Secondary Outcome Measures
Name Time Method Safety; Adverse events 1.0, 2.0, 4.0, 12.0, 24.0, 48.0 and 72.0 hours Safety monitoring, vital sign