Type II Diabetes MellitusPhase 1NCT03601910
Clinical Study to Compare the Pharmacokinetic Characteristics and Safety Between CKD-380 10mg and D308 10mg
A Phase 1 study testing D308 10mg Tab. and CKD-380 10mg Tab. in people with Type II Diabetes Mellitus, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This study is an open-label, randomized, fasted, single-dose, 2-way crossover study to compare the pharmacokinetic characteristics and safety between CKD-380 10mg and D308 10mg in healthy male adults. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- D308 10mg Tab. and CKD-380 10mg Tab.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Jul 2018to 9 Nov 2018
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 19 to 45 years old healthy male subject at the screening
- Subject with a body weight more than 50kg and less than ±20% of ideal body weight at the screening(* Ideal body weight = {Height(cm) - 100}x0.9)
- Subject who is able to provide written informed consent and decided on his own participation after understanding fully to hear a detailed explanation in the clinical study
Who cannot join
- Subject who has a disease or history of clinically significant cardiovascular system, respirator, kidney, endocrine system, blood system, digestive system, central nervous system(CNS), urinary system, musculoskeletal system, psychiatric system or malignant tumor etc.
- Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect investigational product absorption
- Subject who has hypersensitivity to Investigational product(or additives) or any other medicines or medical history of clinically significant hypersensitivity
- Subject who is determined unsuitable for clinical studyl participation by Health Examination(Disease, past disease history Physical, vital sign, Electrocardiography, laboratory test etc.) at the screening
- Subject who has laboratory test results at the screening as below 1) AST or AST > 1.25 times upper limit of normal range 2) Total bilirubin > 1.25 times upper limit of normal range 3) eGFR (estimated Glomerular Filtration Rate) < 60 mL/min/1.73 m2 4) Positive results of HBsAg, Anti-HCV Ab, HIV Ag/Ab and Syphilis reagin test 5) Glucose(under fasting condition) < 50mg/dL or >110mg/dL
- Subject who has hypersensitivity to investigational product, peanut, or bean
Show all 17Show fewer
- Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- Subject who shows Systolic Blood Pressure ≥140 or <90 mmHg or Diastolic Blood Pressure ≥90 or <60 mmHg at screening after rest longer than 5 minute at the screening
- Subject who has history of drug abuse
- Subject who has too much caffeine and alcohol(Caffeine: > 5 cup/day, Alcohol > 210 g/week) / Smoker(>10 cigarettes/day)
- Subject who had the Investigational Product(IP) administration at other clinical studies or bioequivalence tests within 90 days prior to the first IP administration
- Subject who has taken drug-metabolizing enzyme induction and/or inhibition drug(such as barbital, etc.) within 30days prior to the first Investigational Product administration
- Subject who has donated whole blood within 60 days or component blood within 30days prior to the first Investigational Product administration
- Subject who has foods containing grapefruit within 7days prior to the first Investigational Product administration
- Subject who has taken ETC(Ethical The Counter) Drug or herb medicine within 14 days or OTC(Over The Counter) Drug or vitamin supplement within 7 days prior to the first Investigational Product administration
- Subject who is nat able to have foods containing caffeine, drinking alcohol or Smoking during from 24hours before admission to discharge hospitalization
- Subject who is not eligible for participation in clinical study by investigator's decision including another reason
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul
About this study
Official title: An Open-label, Randomized, Fasted, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetic Characteristics and Safety Between CKD-380 10mg and D308 10mg in Healthy Male Adults
This study is an open-label, randomized, fasted, single-dose, 2-way crossover study to compare the pharmacokinetic characteristics and safety between CKD-380 10mg and D308 10mg in healthy male adults.
Read the detailed description
To healthy male subjects of thirty-four (34), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: D308 10mg Tab. / Test drug: CKD-380 10mg Tab.
Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- D308 10mg Tab., CKD-380 10mg Tab.
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D308 10mg Tab.Drug
D308 10mg Tab.1T single oral administration under fasting condition
CKD-380 10mg Tab.Drug
CKD-380(Dapagliflozin) 10mg Tab.1T single oral administration under fasting condition
| Study group | Role | What they receive |
|---|---|---|
| A group | Experimental | 1. Period 1: D308 10mg Tab. 1T
2. Period 2: CKD-380 10mg Tab. 1T Receives: Drug: D308 10mg Tab.; Drug: CKD-380 10mg Tab. |
| B group | Experimental | 1. Period 1: CKD-380 10mg Tab. 1T
2. Period 2: D308 10mg Tab. 1T Receives: Drug: D308 10mg Tab.; Drug: CKD-380 10mg Tab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of CKD-380 and D308
Area under the CKD-380/D308 concentration in blood-time curve from zero to the final
Measured: Pre-dose(0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours
Cmax of CKD-380 and D308
The maximum CKD-380/D308 concentration in blood sampling time t
Measured: Pre-dose(0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start16 Jul 2018
- Primary completion21 Sep 2018 (estimated)
- Study completion9 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Diabetes MellitusStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seunghoon Han, Professor, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601910
- Sponsor's protocol ID
- 181BE18007
- Status last verified
- Jul 2018
- First submitted
- 9 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Fasted, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetic Characteristics and Safety Between CKD-380 10mg and D308 10mg in Healthy Male Adults
- ClinicalTrials.gov ID
- NCT03601910
- Acronym / sponsor ID
- 181BE18007
- Conditions
- Type II Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 21 Sep 2018 (estimated)
- Study completion
- 9 Nov 2018 (estimated)
- First posted
- 26 Jul 2018 (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.
This study is an open-label, randomized, fasted, single-dose, 2-way crossover study to compare the pharmacokinetic characteristics and safety between CKD-380 10mg and D308 10mg in healthy male adults.
Detailed description
To healthy male subjects of thirty-four (34), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: D308 10mg Tab. / Test drug: CKD-380 10mg Tab.
Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | Experimental | Drug: D308 10mg Tab., Drug: CKD-380 10mg Tab.1. Period 1: D308 10mg Tab. 1T 2. Period 2: CKD-380 10mg Tab. 1T |
| B group | Experimental | Drug: D308 10mg Tab., Drug: CKD-380 10mg Tab.1. Period 1: CKD-380 10mg Tab. 1T 2. Period 2: D308 10mg Tab. 1T |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 19 to 45 years old healthy male subject at the screening
- Subject with a body weight more than 50kg and less than ±20% of ideal body weight at the screening(* Ideal body weight = {Height(cm) - 100}x0.9)
- Subject who is able to provide written informed consent and decided on his own participation after understanding fully to hear a detailed explanation in the clinical study
Key exclusion criteria (17 listed)
- Subject who has a disease or history of clinically significant cardiovascular system, respirator, kidney, endocrine system, blood system, digestive system, central nervous system(CNS), urinary system, musculoskeletal system, psychiatric system or malignant tumor etc.
- Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect investigational product absorption
- Subject who has hypersensitivity to Investigational product(or additives) or any other medicines or medical history of clinically significant hypersensitivity
- Subject who is determined unsuitable for clinical studyl participation by Health Examination(Disease, past disease history Physical, vital sign, Electrocardiography, laboratory test etc.) at the screening
- Subject who has laboratory test results at the screening as below 1) AST or AST > 1.25 times upper limit of normal range 2) Total bilirubin > 1.25 times upper limit of normal range 3) eGFR (estimated Glomerular Filtration Rate) < 60 mL/min/1.73 m2 4) Positive results of HBsAg, Anti-HCV Ab, HIV Ag/Ab and Syphilis reagin test 5) Glucose(under fasting condition) < 50mg/dL or >110mg/dL
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 |
|---|---|---|
| D308 10mg Tab.D308 10mg Tab.1T single oral administration under fasting condition | Drug | A group, B group |
| CKD-380 10mg Tab.CKD-380(Dapagliflozin) 10mg Tab.1T single oral administration under fasting condition | Drug | A group, B group |
Primary outcome
AUCt of CKD-380 and D308
Time frame: Pre-dose(0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours
Area under the CKD-380/D308 concentration in blood-time curve from zero to the final
Cmax of CKD-380 and D308
Time frame: Pre-dose(0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours
The maximum CKD-380/D308 concentration in blood sampling time t
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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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.
Seunghoon Han, Professor principal investigator
The Catholic University of Korea
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 D308 10mg Tab. and CKD-380 10mg Tab. in people with Type II Diabetes Mellitus, 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 3 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 26 Jul 2018. 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?
Results are not available in the source record.
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 CKD-380 and D308 (time frame: Pre-dose(0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 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 26 Jul 2018.