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

NCT05787873 | Completed Phase 1

• 1 other identifier: SIPS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

diabetes mellitus; Fixed-dose combination; Bioequivalence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• AUCinf of SIPS-2209-1

  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

  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

  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

  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

  predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours

Study Arms (2)

Sequence A

EXPERIMENTAL

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; Drug: SIPS-2209-2, SIPS-2209-3

Sequence B

EXPERIMENTAL

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; Drug: SIPS-2209-2, SIPS-2209-3

Interventions

SIPS-2209-1 DRUG

QD, PO

Sequence A; Sequence B

SIPS-2209-2, SIPS-2209-3 DRUG

QD, PO

Sequence A; Sequence B

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult volunteers aged ≥ 19 years
• Male for body weight ≥50 kg, female for body weight ≥45 kg
• Calculated body mass index (BMI) of 18 to 30 kg/m2
• Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
• Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and ECG results at screening.
• Those who agree to contraception during the participation of clinical trial.
• 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

You may not qualify if:

• Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
• 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.
• Those who donated whole blood or apheresis within 8 weeks or 2 weeks respectfully, or received blood transfusion within a month.
• Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
• 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)
• 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

Sponsors & Collaborators

• Samik Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Samik Pharmaceutical Co. Ltd.

Incheon, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Young Ee KWON, Ph.D

  Samik Pharmaceutical Co. Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 28, 2023
• Study Start: August 30, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 21, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)