A Pharmacokinetic Study of DW6013 (FDC of Linagliptin and Metformin) in Healthy Adult Volunteers
- Registration Number
- NCT05874167
- Lead Sponsor
- Dong Wha Pharmaceutical Co. Ltd.
- Brief Summary
This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of DW6013 and each component in healthy adult volunteers in fast condition.
- Detailed Description
This is a Phase 1, randomized, open-label, Oral, Single-dose, two-way crossover study in healthy subjects
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Healthy subjects aged up to 19 years
- Subjects weighing at least 50.0 kg and no more than 100 kg (inclusive) with a BMI between 18.5 kg/m2 and 30.0 kg/m2
- Subjects with neither congenital nor chronic diseases requiring treatment, and no abnormal symptoms or findings upon medical examination
- Subjects considered eligible for the study participation in accordance to the results of clinical laboratory tests, vital signs, physical examinations and 12-lead ECG conducted at the time of screening, based on the investigational product (IP) characteristics
- Subjects who has a full understanding in participation of the study, voluntarily provide a written consent in participation, and give full agreement in following the subject guidelines throughout the entire study period
Exclusion Criteria
- Subjects with any clinically significant hepatic, renal, nervous, respiratory, endocrine, circulatory, tumor, genitourinary, cardiovascular, digestive, musculoskeletal systemic diseases or other medical history
- Pregnant subjects with a positive urine HCG test, or lactating female subjects
- Subjects taking drugs known to significantly induce or inhibit drug metabolizing enzymes, including barbitals within 1 months prior to the first IP administration
- Subjects with clinically significant 12-lead ECG findings at the time of screening
- Subjects with a past history of drug abuse or a positive urine drug test
- Subjects with SBP ≥ 150 mmHg or ≤ 90 mmHg; DBP ≥ 100 mmHg or ≤ 60 mmHg; PR ≤ 40 bpm or ≥ 100 bpm at the time of screening
- Subjects following an unusual diet or consumption of food which may affect the absorption, distribution, metabolism and excretion of the IP
- Subjects who have administered any prescription drugs or herbal medicines that may affect the characteristics of clinical investigational drugs within 2 weeks prior to the first administration date, or have administered any over-the-counter (OTC) or vitamin preparations within 10 days
- Subjects who have participated and were given any other study drugs in other clinical study within 6 months prior to the first IP administration
- Subjects who have consistently drunk alcohol within 6 months
- Subjects who have smoked more than 10 cigarettes/day on average
- Subjects who have eaten or cannot refrain from eating grapefruit (grapefruit)-containing food from 48 hours before the first administration until the time of PSV
- Subjects who have consumed or cannot refrain from consuming caffeine-containing food during the period from 24 hours prior to administration of each period to the time of the last blood sampling
- Subjects who have done and are unable to refrain from strenuous activity
- Subjects who are planning for pregnancy or not willing to use a medically reliable forms of contraception
- Subjects otherwise considered ineligible for participation due to other reasons including clinical laboratory test results not mentioned in the inclusion/exclusion criteria at the investigator's discretion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence A DW6013 Period 1: Linagliptin and Metformin / Period 2: DW6013 Sequence B DW6013 Period 1: DW6013 / Period 2: Linagliptin and Metformin
- Primary Outcome Measures
Name Time Method Cmax up to 72 hours Cmax of Linagliptin and Metformin
AUC0-t up to 72 hours AUC0-t of Linagliptin and Metformin
- Secondary Outcome Measures
Name Time Method AUCinf up to 72 hours AUCinf of Linagliptin and Metformin
CL/F up to 72 hours CL/F of Linagliptin and Metformin
Tmax up to 72 hours Tmax of Linagliptin and Metformin
AUCextra up to 72 hours AUCextra of Linagliptin and Metformin
t1/2 up to 72 hours t1/2 of Linagliptin and Metformin
Vd/F up to 72 hours Vd/F of Linagliptin and Metformin
Trial Locations
- Locations (1)
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of