GERDPhase 1NCT03211143
A Study to Compare PK, PD and Safety of CKD-381 in Healthy Subjects
A Phase 1 study testing CKD-381 and Nexium in people with GERD, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A Study to compare Pharmacokinetics, Pharmacodynamics and safety of CKD-381 and D027 in healty subjects Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- GERD
- What is being tested?
- CKD-381 and Nexium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jun 2017to 28 Aug 2017
- 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
- Between 19 aged and 55 aged in healthy adult
- Body weight more than 55kg in male, 50kg in female
- Body Mass Index more than 18.5 and under 25(body mass index=kg/m2)
- If female, must include more than one among the items
- The menopause(there is no natural menses for at least 2 years)
- Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or other methods of infertility condition
- If men has sexual life with women of childbearing age, Necessarily he agrees that use condoms and do not sperm donation until two months during clinical trials and after the final dosage of investigational products
- Those who fully understand about this clinical trials after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent.
Who cannot join
- Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc), kidney(severe renal impairment, etc), nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system(heart failure, etc) or mental illness, or a history of mental disease.
- Have a gastrointestinal disease history that can effect drug absorption(Crohn's disease, ulcers, etc.) or surgery(except simple appendectomy or hernia surgery)
- Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family
- Have a history of fructose intolerance, glucose-galactose malabsorbtion or sucrase isomaltase deficiency
- Defined by the following laboratory parameters
- Na>1.5 upper limit of normal range
Show all 23Show fewer
- AST, ALT>1.25 upper limit of normal range
- Total bilirubin>1.5 upper limit of normal range
- CPK>1.5 upper limit of normal range
- eGFR(using by MDRD method)<60mL/min/1.73m2
- Positive for HBV, HCV and HIV by serology test
- Positive by urine drug abuse test.
- Sitting SBP > 140mmHg or < 90mmHg, sitting DBP > 90mmHg or < 60mmHg, after 5 minutes break.
- Have a history of drug abuse
- Subject takes ethical drug or herbal medicine within 14 days, OTC within 7 days before the beginning of study treatment but investigator determine that the taking drug affect this study or could affect the safety of subjects.
- Subject who takes inhibitor and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30 days.
- smoker(except the one who have stopped smoking more than 90days before beginning of study treatment)
- A heavy caffeine consumer(caffeine>5 cups/day), alcohol consumer(alcohol>210g/week),
- Taking foods containing grapefruit within 7 days before the beginning of study treatment(ex. Drinking containing grapefruit of 1L per a day or more within 7 days before the beginning of study treatment)
- Subject who treated with any investigational drugs within 90 days before the beginning of study treatment
- Previously donate whole blood within 60 days or component blood within 30 days.
- Pregnant or lactating women.
- An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Multiple-dose, and Crossover Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of CKD-381 and D027 in Healthy Subjects
A Study to compare Pharmacokinetics, Pharmacodynamics and safety of CKD-381 and D027 in healty subjects
Read the detailed description
A randomized, open-label, multiple-dose, and crossover study to compare pharmacokinetics, pharmacodynamics and safety of CKD-381 and D027 in healthy subjects
- Conditions
- GERD
- Being tested
- CKD-381, Nexium
- Keywords
- GERD, CKD-381, Nexium, Bioequivalence
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-381Drug
Also called Esomeprazole 20mg+Sodum bicarbonate 800mg
Test drug: CKD-381
NexiumDrug
Also called Esomeprazole magnesium trihydrate 22.3mg
Reference drug: Nexium
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | TR group
Period 1: Test drug(CKD-381), 1 tablet administered before the breakfast during 7 days
Period 2: Reference drug(Nexium), 1 tablet administered before the breakfast during 7 days Receives: Drug: CKD-381; Drug: Nexium |
| B | Experimental | RT group
Period 1: Reference drug(Nexium), 1 tablet administered before the breakfast during 7 days
Period 2: Test drug(CKD-381), 1 tablet administered before the breakfast during 7 days Receives: Drug: CKD-381; Drug: Nexium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics(Area under the plasma drug concentration-time curve within a dosing interval(AUCτ))
Evaluating PK of Esomeprazole after Multiple dose
Measured: 0h~12 h
Pharmacodynamics(Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose)
Evaluating PD for ambulatory 24hr pH monitor
Measured: Baseline versus Multiple dose during 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start20 Jun 2017
- Primary completion28 Aug 2017
- Study completion28 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GERDStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Choon Ok Kim, MD, Principal investigator, Clinical Trials center, Yonsei Univ. Health system
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211143
- Sponsor's protocol ID
- 173HPS16024
- Status last verified
- Jun 2017
- First submitted
- 5 Jul 2017
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim D, Park MS, Yoo BW, Hong T, Park SJ, Kim CO. The safety, pharmacodynamics, and pharmacokinetics of immediate-release formulation containing esomeprazole 20 mg/sodium bicarbonate 800 mg in healthy adult male. Drug Des Devel Ther. 2019 Sep 3;13:3151-3159. doi: 10.2147/DDDT.S212491. eCollection 2019.
PubMed 31564831
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple-dose, and Crossover Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of CKD-381 and D027 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03211143
- Acronym / sponsor ID
- 173HPS16024
- Conditions
- GERD
- Keywords
- GERD, CKD-381, Nexium, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 28 Aug 2017 (actual)
- Study completion
- 28 Aug 2017 (actual)
- First posted
- 7 Jul 2017 (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 Study to compare Pharmacokinetics, Pharmacodynamics and safety of CKD-381 and D027 in healty subjects
Detailed description
A randomized, open-label, multiple-dose, and crossover study to compare pharmacokinetics, pharmacodynamics and safety of CKD-381 and D027 in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: CKD-381, Drug: NexiumTR group Period 1: Test drug(CKD-381), 1 tablet administered before the breakfast during 7 days Period 2: Reference drug(Nexium), 1 tablet administered before the breakfast during 7 days |
| B | Experimental | Drug: CKD-381, Drug: NexiumRT group Period 1: Reference drug(Nexium), 1 tablet administered before the breakfast during 7 days Period 2: Test drug(CKD-381), 1 tablet administered before the breakfast during 7 days |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Between 19 aged and 55 aged in healthy adult
- Body weight more than 55kg in male, 50kg in female
- Body Mass Index more than 18.5 and under 25(body mass index=kg/m2)
- If female, must include more than one among the items
- If men has sexual life with women of childbearing age, Necessarily he agrees that use condoms and do not sperm donation until two months during clinical trials and after the final dosage of investigational products
Key exclusion criteria (23 listed)
- Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc), kidney(severe renal impairment, etc), nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system(heart failure, etc) or mental illness, or a history of mental disease.
- Have a gastrointestinal disease history that can effect drug absorption(Crohn's disease, ulcers, etc.) or surgery(except simple appendectomy or hernia surgery)
- Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family
- Have a history of fructose intolerance, glucose-galactose malabsorbtion or sucrase isomaltase deficiency
- Defined by the following laboratory parameters
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 |
|---|---|---|
| CKD-381Also: Esomeprazole 20mg+Sodum bicarbonate 800mgTest drug: CKD-381 | Drug | A, B |
| NexiumAlso: Esomeprazole magnesium trihydrate 22.3mgReference drug: Nexium | Drug | A, B |
Primary outcome
Pharmacokinetics(Area under the plasma drug concentration-time curve within a dosing interval(AUCτ))
Time frame: 0h~12 h
Evaluating PK of Esomeprazole after Multiple dose
Pharmacodynamics(Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose)
Time frame: Baseline versus Multiple dose during 7days
Evaluating PD for ambulatory 24hr pH monitor
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 21 Nov 2017.
- Derived from this study: PubMed 31564831Kim D, Park MS, Yoo BW, Hong T, Park SJ, Kim CO. The safety, pharmacodynamics, and pharmacokinetics of immediate-release formulation containing esomeprazole 20 mg/sodium bicarbonate 800 mg in healthy adult male. Drug Des Devel Ther. 2019 Sep 3;13:3151-3159. doi: 10.2147/DDDT.S212491. eCollection 2019.
- Individual participant dataSharing planned: No
Related trials for GERD
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
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.
Choon Ok Kim, MD principal investigator
Clinical Trials center, Yonsei Univ. Health system
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 CKD-381 and Nexium in people with GERD, 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 8 inclusion and 23 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 21 Nov 2017. 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?
Pharmacokinetics(Area under the plasma drug concentration-time curve within a dosing interval(AUCτ)) (time frame: 0h~12 h). 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?
On the ClinicalTrials.gov record for NCT03211143, which also lists 1 linked publication.
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 21 Nov 2017.