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

Healthy Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05787873
• Other study ID #: SIPS
• Status: Completed
• Phase: Phase 1
• Start date: August 30, 2022
• Est. completion date: September 21, 2022

Study information

• Verified date: April 2023
• Source: Samik Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 21, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• SIPS-2209-1
QD, PO
• SIPS-2209-2, SIPS-2209-3
QD, PO

Locations

Country	Name	City	State
Korea, Republic of	Samik Pharmaceutical Co. Ltd.	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Samik Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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