A Pharmacokinetic Study of DW6012 (FDC of Dapagliflozin and Sitagliptin) in Healthy Adult Volunteers

• Status: Completed
• Trial end date: 2022-03-28
• Target enrollment: 0
• Participant gender: All

Summary

This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of DW6012 and each component in healthy adult volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dong Wha Pharmaceutical Co. Ltd.
• Treatments: Dapagliflozin; Sitagliptin Phosphate

Criteria

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

• Subjects with genetic problems such as Lapp lactase deficiency (Lapp) or galactose intolerant galactose due to galactose intolerance

• Subjects with a past medical history of gastrointestinal disease or gastrointestinal surgeries which may affect the absorption, distribution, metabolism and excretion of the IP

• Pregnant subjects with a positive urine HCG test, or lactating female subjects

• Subjects with hypersensitivity reactions or a clinically significant medical history of hypersensitivity reactions to drug substances and additives containing drug substances or other drugs

• Subjects with clinically significant 12-lead ECG findings at the time of screening

• Subjects with clinically significant laboratory test results as follows: Liver function test (AST, ALT, ALP, γ-GTP and total bilirubin), Creatinine, eGFR

• 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 taking drugs known to significantly induce or inhibit drug metabolizing enzymes, including barbitals within 1 months prior to the first IP administration

• 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