Diabetes type2Phase 1NCT05928637
A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of D745, D759, and D150
A Phase 1 study testing D745, D759, D150 in people with Diabetes type2, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A clinical trial to compare the pharmacokinetic characteristics and safety among D745, D759, and D150 in healthy subjects Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes type2
- What is being tested?
- D745, D759, D150
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jul 2023to 5 Sep 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult aged between 19 to 50 at screening
- Weight ≥ 55kg(man) or 50kg(woman) with ideal body weight ±20%
- Those who don't have clinically significant sign of diseases including history of 5 years.
- Those who have been confirmed to be appropriate throughout screening health examination.
- Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial
Who cannot join
- Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Haemato-oncology disorder, Cardiovascular disorder or Psychical disorder.
- Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption.
- Those who have hypersensitivity to the main constituents or components of the investigational drug such as empagliflozin, metformin.
- History of drug abuse.
- Following results in clinical examination
- Na < 135 mEq/L
Show all 25Show fewer
- K < 3.4 mEq/L
- Ca > 10.5 mg/dL
- AST or ALT > 1.25 times more than normal range
- Total bilirubin > 1.5 times more than normal range
- Total cholesterol > 1.5 times more than normal range
- CKD-EPI < 60 mL/min/1.73 m2
- HBsAg, HCV Ab, HIV Ag/Ab, Syphilis reagin test = positive
- Under 5 min resting condition, systolic blood pressure ≥150 mmHg or or <90 mmHg, diastolic blood pressure ≥100 mmHg or <50 mmHg.
- Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Those who had medical examination requiring radioactive iodine contrast material injected through IV 48 hours prior to first IP administration.
- Those who received investigational products or participated in bioequivalence test within 180 days before the first administration of clinical trial drugs
- Those who donated whole blood within 60 days before the first date of administration and donated ingredients within 30 days or received blood transfusion in 30 days
- Those who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, or who have used drugs that may interfere with this study within 30 days before the first dosing day
- Those who have used ETC, herbal medicinal preparations, OTC, vitamins 10 days before the first dosing date.
- Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 210g/week, smoking> 10 cigarettes/day) and not able to stop on smoking, caffeine and alcohol
- Those who can't resist caffeine, drinking and smoking from 9am of administration day till discharge date.
- Those who agree to contraception from the date of consent form was written till 2 weeks after the last dosing day and decide not to provide sperm during the participation of clinical trial
- Woman who are pregnant or breastfeeding
- Those who are deemed insufficient to participate in clinical study by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Multiple-dose, Three-way Crossover Study to Compare the Pharmacokinetic Characteristics and Safety Among D745, D759, and D150 in Healthy Subjects
A clinical trial to compare the pharmacokinetic characteristics and safety among D745, D759, and D150 in healthy subjects
Read the detailed description
An open-label, randomized, multiple-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety among D745, D759, and D150 in healthy subjects
- Conditions
- Diabetes type2
- Being tested
- D745, D759, D150
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D745, D759, D150Drug
QD, PO for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | * Period 1: oral dose of D745 1 tablet.
* Period 2: multiple oral dose of 1 tablet of D759 and 2 tablets of D150.
* Period 3: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150. Receives: Drug: D745, D759, D150 |
| Sequence 2 | Experimental | * Period 1: oral dose of D745 1 tablet.
* Period 2: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150.
* Period 3: multiple oral dose of 1 tablet of D759 and 2 tablets of D150. Receives: Drug: D745, D759, D150 |
| Sequence 3 | Experimental | * Period 1: multiple oral dose of 1 tablet of D759 and 2 tablets of D150.
* Period 2: oral dose of D745 1 tablet.
* Period 3: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150. Receives: Drug: D745, D759, D150 |
| Sequence 4 | Experimental | * Period 1: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150.
* Period 2: multiple oral dose of 1 tablet of D759 and 2 tablets of D150.
* Period 3: oral dose of D745 1 tablet. Receives: Drug: D745, D759, D150 |
| Sequence 5 | Experimental | * Period 1: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150.
* Period 2: oral dose of D745 1 tablet.
* Period 3: multiple oral dose of 1 tablet of D759 and 2 tablets of D150. Receives: Drug: D745, D759, D150 |
| Sequence 6 | Experimental | * Period 1: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150.
* Period 2: multiple oral dose of 1 tablet of D759 and 2 tablets of D150.
* Period 3: oral dose of D745 1 tablet. Receives: Drug: D745, D759, D150 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
Area under the concentration-time curve time zero to time
Measured: [0d, 12d, 24d] pre-dose, [2d, 14d, 26d] pre-dose, [3d, 15d, 27d] pre-dose, [4d, 16d, 28d] pre-dose, and 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12h, [5d, 17d, 29d] 24h
Cmax
Maximum plasma concentration of the drug
Measured: [0d, 12d, 24d] pre-dose, [2d, 14d, 26d] pre-dose, [3d, 15d, 27d] pre-dose, [4d, 16d, 28d] pre-dose, and 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12h, [5d, 17d, 29d] 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start10 Jul 2023
- Primary completion29 Aug 2023
- Study completion5 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes type2Studies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928637
- Sponsor's protocol ID
- A125_03DDI2228
- Status last verified
- Jun 2023
- First submitted
- 26 Jun 2023
- Last updated
- 12 Mar 2024
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multiple-dose, Three-way Crossover Study to Compare the Pharmacokinetic Characteristics and Safety Among D745, D759, and D150 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05928637
- Acronym / sponsor ID
- A125_03DDI2228
- Conditions
- Diabetes type2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 3 Jul 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.
A clinical trial to compare the pharmacokinetic characteristics and safety among D745, D759, and D150 in healthy subjects
Detailed description
An open-label, randomized, multiple-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety among D745, D759, and D150 in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: D745, D759, D150* Period 1: oral dose of D745 1 tablet. * Period 2: multiple oral dose of 1 tablet of D759 and 2 tablets of D150. * Period 3: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150. |
| Sequence 2 | Experimental | Drug: D745, D759, D150* Period 1: oral dose of D745 1 tablet. * Period 2: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150. * Period 3: multiple oral dose of 1 tablet of D759 and 2 tablets of D150. |
| Sequence 3 | Experimental | Drug: D745, D759, D150* Period 1: multiple oral dose of 1 tablet of D759 and 2 tablets of D150. * Period 2: oral dose of D745 1 tablet. * Period 3: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150. |
| Sequence 4 | Experimental | Drug: D745, D759, D150* Period 1: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150. * Period 2: multiple oral dose of 1 tablet of D759 and 2 tablets of D150. * Period 3: oral dose of D745 1 tablet. |
| Sequence 5 | Experimental | Drug: D745, D759, D150* Period 1: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150. * Period 2: oral dose of D745 1 tablet. * Period 3: multiple oral dose of 1 tablet of D759 and 2 tablets of D150. |
| Sequence 6 | Experimental | Drug: D745, D759, D150* Period 1: multiple oral dose of 1 tablet of D745, 1 tablet of D759, and 2 tablets of D150. * Period 2: multiple oral dose of 1 tablet of D759 and 2 tablets of D150. * Period 3: oral dose of D745 1 tablet. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult aged between 19 to 50 at screening
- Weight ≥ 55kg(man) or 50kg(woman) with ideal body weight ±20%
- Those who don't have clinically significant sign of diseases including history of 5 years.
- Those who have been confirmed to be appropriate throughout screening health examination.
- Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial
Key exclusion criteria (25 listed)
- Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Haemato-oncology disorder, Cardiovascular disorder or Psychical disorder.
- Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption.
- Those who have hypersensitivity to the main constituents or components of the investigational drug such as empagliflozin, metformin.
- History of drug abuse.
- Following results in clinical examination
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 |
|---|---|---|
| D745, D759, D150QD, PO for 5 days | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
AUCt
Time frame: [0d, 12d, 24d] pre-dose, [2d, 14d, 26d] pre-dose, [3d, 15d, 27d] pre-dose, [4d, 16d, 28d] pre-dose, and 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12h, [5d, 17d, 29d] 24h
Area under the concentration-time curve time zero to time
Cmax
Time frame: [0d, 12d, 24d] pre-dose, [2d, 14d, 26d] pre-dose, [3d, 15d, 27d] pre-dose, [4d, 16d, 28d] pre-dose, and 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12h, [5d, 17d, 29d] 24h
Maximum plasma concentration of the drug
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 12 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 D745, D759, D150 in people with Diabetes type2, run by Chong Kun Dang Pharmaceutical 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 5 inclusion and 25 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 12 Mar 2024. 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 (time frame: [0d, 12d, 24d] pre-dose, [2d, 14d, 26d] pre-dose, [3d, 15d, 27d] pre-dose, [4d, 16d, 28d] pre-dose, and 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12h, [5d, 17d, 29d] 24h). 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 12 Mar 2024.