HealthyPhase 1NCT05787873
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of SIPS-2209-1 in Healthy Korean Volunteers
A Phase 1 study testing SIPS-2209-1 and SIPS-2209-2, SIPS-2209-3 in people with Healthy, run by Samik Pharmaceutical Co. Ltd. at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SIPS-2209-1 and SIPS-2209-2, SIPS-2209-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Aug 2022to 21 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
- Those who are deemed insufficient to participate in this clinical trial by investigators.
- Woman who are pregnant or breastfeeding.
- Those who have a history of clinically significant mental illness
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- SIPS-2209-1, SIPS-2209-2, SIPS-2209-3
- Keywords
- diabetes mellitus, Fixed-dose combination, Bioequivalence
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIPS-2209-1Drug
QD, PO
SIPS-2209-2, SIPS-2209-3Drug
QD, PO
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: SIPS-2209-1; Drug: SIPS-2209-2, SIPS-2209-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of SIPS-2209-1
AUCt: Area under the concentration-time curve from time zero to time
Measured: 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
Measured: 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
AUCinf : AUC from time 0 to infinity
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start30 Aug 2022
- Primary completion1 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samik Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young Ee KWON, Ph.D, Study director, Samik Pharmaceutical Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787873
- Sponsor's protocol ID
- SIPS
- Status last verified
- Apr 2023
- First submitted
- 5 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05787873
- Acronym / sponsor ID
- SIPS
- Conditions
- Healthy
- Keywords
- diabetes mellitus, Fixed-dose combination, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Samik Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: SIPS-2209-1, Drug: SIPS-2209-2, SIPS-2209-3Period 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 |
| Sequence B | Experimental | Drug: SIPS-2209-1, Drug: SIPS-2209-2, SIPS-2209-3Period 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 |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIPS-2209-1QD, PO | Drug | Sequence A, Sequence B |
| SIPS-2209-2, SIPS-2209-3QD, PO | Drug | Sequence A, Sequence B |
Primary outcome
AUCt of SIPS-2209-1
Time frame: predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours
AUCt: Area under the concentration-time curve from time zero to time
Cmax of SIPS-2209-1
Time frame: 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: Maximum plasma concentration of the drug
5 secondary outcomes
AUCinf of SIPS-2209-1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Ee KWON, Ph.D study director
Samik Pharmaceutical Co. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SIPS-2209-1 and SIPS-2209-2, SIPS-2209-3 in people with Healthy, run by Samik Pharmaceutical Co. Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt of SIPS-2209-1 (time frame: predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.