A Clinical Trial to Evaluate the Pharmacokinetics and Safety of SIPS-2209-1 in Healthy Korean Volunteers

A Clinical Trial to Compare and Evaluate the Safety and Bioequivalence of After Concomitant Administration of "SIPS-2209-2" and "SIPS-2209-3" and Single Administration of "SIPS-2209-1" in Healthy Adult Volunteers in Fasting Conditions.

The goal of this clinical trial is to evaluate of bioequivalence between fixed-dose combination and co-administration of the individual components under fasting conditions in healthy Korean volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: SIPS-2209-1; Drug: SIPS-2209-2, SIPS-2209-3

Detailed Description

40 healthy subjects are administered the corresponding drug for each period, and the drug wash-out period is set to 7 days. Pharmacokinetic samples are collected for up to 36 hours. Pharmacokinetic parameters are compared to evaluate bioequivalence, and additionally, safety are evaluated.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Samik Pharmaceutical Co. Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19 years
2. Male for body weight ≥50 kg, female for body weight ≥45 kg
3. Calculated body mass index (BMI) of 18 to 30 kg/m2
4. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and ECG results at screening.
6. Those who agree to contraception during the participation of clinical trial.
7. Those who agrees to exclude the possibility of pregnancy by using a medically accepted method of contraception from the first administration of investigational medicine to 7 days after the last administration of investigational medicine

Exclusion Criteria:

1. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
2. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month and those who take drug could affect to clinical trial within 10 days before the first administration of investigational products.
3. Those who donated whole blood or apheresis within 8 weeks or 2 weeks respectfully, or received blood transfusion within a month.
4. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.

5. Those who exceed an alcohol and cigarette consumption criteria write below within 1 month before the first administration of investigational products.

   • Alcohol: Man - 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)

6. Patients with the following diseases

   • Patients with known hypersensitivity reactions such as anaphylaxis or angioedema to investigational drugs and components
   • Patients with pancreatitis
   • Patients with heart failure or a history of heart failure
   • Patients with active bladder cancer or a history of bladder cancer
   • Patients with hepatic impairment
   • Patients with severe renal impairment
   • Patients with diabetic ketoacidosis, diabetic coma and pre-coma, patients with type 1 diabetes
   • Before and after surgery, patients with severe infections, patients with severe trauma
   • Patients with gross hematuria not investigated
   • Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
7. Those who are deemed insufficient to participate in this clinical trial by investigators.
8. Woman who are pregnant or breastfeeding.
9. Those who have a history of clinically significant mental illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A; Period 1: SIPS-2209-1 - A single oral dose of 1 tablet under fasting condition Period 2: SIPS-2209-2, SIPS-2209-3 - A single oral dose of 2 tablets under fasting condition	Drug: SIPS-2209-1; QD, PO; Drug: SIPS-2209-2, SIPS-2209-3; QD, PO
Experimental: Sequence B; Period 1: SIPS-2209-2, SIPS-2209-3 - A single oral dose of 2 tablets under fasting condition Period 2: SIPS-2209-1 - A single oral dose of 1 tablet under fasting condition	Drug: SIPS-2209-1; QD, PO; Drug: SIPS-2209-2, SIPS-2209-3; QD, PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt of SIPS-2209-1	AUCt: Area under the concentration-time curve from time zero to time	predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours
Cmax of SIPS-2209-1	Cmax: Maximum plasma concentration of the drug	predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf of SIPS-2209-1	AUCinf : AUC from time 0 to infinity	predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours
CL/F of SIPS-2209-1	CL/F : Clearance	predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours
Tmax of SIPS-2209-1	Tmax : Time to maximum plasma concentration of drug	predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours
t1/2 of SIPS-2209-1	t1/2 : Terminal half-life	predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours
Vd/F of SIPS-2209-1	Vd/F : Volume of distribution based on the terminal phase	predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours

Collaborators and Investigators

• Sponsor: Samik Pharmaceutical Co. Ltd.
• Investigators: Study Director: Young Ee KWON, Ph.D, Samik Pharmaceutical Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 21, 2022

Study Registration Dates

• First Submitted: March 5, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Bioequivalence; diabetes mellitus; Fixed-dose combination
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: SIPS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No