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

• Sponsor: SK Chemicals Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05453786
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3.3
• Patients Per Site Per Month: 15.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: SID1903; Drug: SID1903-R1/SID1903-R2	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 23, 2022
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence A Period 1: SID1903-R1, SID1903-R2 / Period 2: SID1903	Drug: SID1903; Single oral administration of SID1903 after an overnight fast; Drug: SID1903-R1/SID1903-R2; Single oral administration of SID1903-R1 and SID1903-R2 after an overnight fast
Experimental: Sequence B - Period 1: SID1903 / Period 2: SID1903-R1, SID1903-R2	Drug: SID1903; Single oral administration of SID1903 after an overnight fast; Drug: SID1903-R1/SID1903-R2; Single oral administration of SID1903-R1 and SID1903-R2 after an overnight fast

Outcome Measures

Primary Outcome Measures

1. AUC0-t [up to 72hours]

2. Cmax [up to 72hours]

Secondary Outcome Measures

1. Tmax [up to 72hours]

2. AUCinf [up to 72hours]

3. t1/2 [up to 72hours]

4. CL/F [up to 72hours]

5. Vd/F [up to 72hours]

6. λz [up to 72hours]

7. MRT [up to 72hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chungbuk National University Hospital	Cheongju-si		Korea, Republic of

Sponsors and Collaborators

• SK Chemicals Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SK Chemicals Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05453786
• Other Study ID Numbers: SID1903_002
• First Posted: Jul 12, 2022
• Last Update Posted: Jul 12, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 12, 2022