Clinical trial NCT05453786: A Pharmacokinetic Study of SID1903 (FDC of Dapagliflozin and Sitagliptin) in Healthy Adult Volunteers
Official title: A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of SID1903 (Fixed-dose Combination) or Loose Combination in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-12
Enrollment: 51
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of SID1903 and SID1903-R1/SID1903-R2 in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects aged between 19 years and 55 years(inclusive)
* 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 (inclusive)
* 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 vital signs, physical examinations, 12-lead ECG, clinical laboratory tests (including hematology, blood chemistry, urinalysis, serology, etc.) and urine drug screening 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, genitourinary, cardiovascular, digestive, musculoskeletal systemic diseases, psychosis disorders, or other medical history
* Subjects with a past medical history of gastrointestinal disease or gastrointestinal surgeries
* 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
* 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 ≥ 140 mmHg or ≤ 90 mmHg; DBP ≥ 90 mmHg or ≤ 60 mmHg; PR ≤ 50 beats/min or ≥ 100 beat/min
* Subjects following an unusual diet or consumption of food which may affect the absorption, distribution, metabolism and excretion of the IP
* Subjects taking drugs known to significantly induce or inhibit drug metabolizing enzymes, including barbitals 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 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

Primary outcomes:
measure: AUC0-t
timeFrame: up to 72hours
measure: Cmax
timeFrame: up to 72hours
Secondary outcomes:
measure: Tmax
timeFrame: up to 72hours
measure: AUCinf
timeFrame: up to 72hours
measure: t1/2
timeFrame: up to 72hours
measure: CL/F
timeFrame: up to 72hours
measure: Vd/F
timeFrame: up to 72hours
measure: λz
timeFrame: up to 72hours
measure: MRT
timeFrame: up to 72hours
Other outcomes:
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
Study officials:
References: