A Pharmacokinetic Study of SID1903 (FDC of Dapagliflozin and Sitagliptin) in Healthy Adult Volunteers

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05453786
• Other study ID #: SID1903_002
• Status: Completed
• Phase: Phase 1
• Start date: June 23, 2022
• Est. completion date: August 11, 2022

Study information

• Verified date: June 2022
• Source: SK Chemicals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 11, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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, ?-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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• SID1903
Single oral administration of SID1903 after an overnight fast
• SID1903-R1/SID1903-R2
Single oral administration of SID1903-R1 and SID1903-R2 after an overnight fast

Locations

Country	Name	City	State
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t		up to 72hours
Primary	Cmax		up to 72hours
Secondary	Tmax		up to 72hours
Secondary	AUCinf		up to 72hours
Secondary	t1/2		up to 72hours
Secondary	CL/F		up to 72hours
Secondary	Vd/F		up to 72hours
Secondary	?z		up to 72hours
Secondary	MRT		up to 72hours