Overview

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