Diabetes Mellitus, Type 2Phase 1NCT05411965
A Study to Evaluate the Pharmacokinetics After Administration of BR3003 and Co-administration of BR3003B and BR3003C.
A Phase 1 study testing BR3003(T), BR3003B(R1) and BR3003C(R2) in people with Diabetes Mellitus, Type 2, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
To perform a comparative evaluation on the pharmacokinetics and the safety after administration of "BR3003" and co-administration of "BR3003B" and "BR3003C" in healthy adults. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- BR3003(T), BR3003B(R1) and BR3003C(R2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Apr 2022to 3 Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who are 19 years old or older at the screening visit.
- Those whose weight is ≥50kg (≥45kg for female subjects) and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2.
- Those without clinically significant congenital or chronic diseases at the screening visit and without any pathological symptom or opinion after an internal medicine examination.
- Those who are judged eligible for the trial by the principal investigator (or an authorized trial doctor) according to diagnostic tests such as hematology test, blood chemistry test, serology test and urinalysis that are predefined according to the characteristics of the investigational drugs in addition to ECG results.
- Those who agree to rule out the possibility of pregnancy through medically acceptable methods of contraception* used by the subject himself/herself or his/her spouse/partner from the first administration of the investigational drugs to 7 days after the last administration of the investigational drugs, and those who agree not to donate their sperms or eggs.
- Those who are given detailed explanations about the trial objectives, components as well as the properties of the investigational drugs and express their voluntary consent to participate in the trial by signing a written consent.
Who cannot join
- Those who currently have or have history of clinically significant diseases related to digestive system, cardiovascular system, endocrine system, respiratory system, hemato-oncology, infection, kidney and genitourinary system, neuropsychiatric system, musculoskeletal system, immune system, Ear-Nose-Throat system, dermal system, ophthalmologic system, etc.
- Those who have medical history of gastrointestinal resection (however, appendectomy and hernia operation shall be excluded) or gastrointestinal system diseases that may influence the absorption of drugs.
- Those who took drugs that substantially induce or inhibit drug-metabolizing enzymes of barbiturates, etc. in 30 days prior to the first administration or who took drugs that can impact the study in 10 days before the first administration. (However, subjects may participate in the study as judged by the principal investigator (or an authorized trial doctor) in consideration of pharmacokinetic or pharmacodynamic characteristics such as the interaction with the investigational drugs and half-life of co-administered drugs.)
- Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational drugs in 180 days prior to the first administration. (The day of the last administration of investigational drugs shall be counted as day 1 of the end of trial.)
- Those who have given a whole blood donation in 60 days prior to the first administration, who have given an apheresis blood donation in 14 days prior to the first administration or who have received blood transfusion in 30 days prior to the first administration.
- Those who are applicable to the following conditions in 30 days prior to the first administration:
Show all 23Show fewer
- Male subjects: average alcohol intake > 21 units/week
- Female subjects: average alcohol intake > 14 units/week
- (1 unit= 50 mL of soju, 30 mL of hard liquor or 250 mL of beer)
- Daily average smoking of >20 cigarettes
- Those who apply to the following criteria
- Those who have medical history of hypersensitivity to major ingredients, other ingredients or additives of the investigational drugs.
- Those who have diabetic ketoacidosis, diabetic coma and precoma or type 1 diabetes.
- Those who are under dialysis.
- Those who currently have or have medical history of heart failure.
- Those who have active bladder cancer or have history of bladder cancer.
- Those who have hepatopathy or severe renal impairment.
- Those who have severe infection or severe trauma before or after surgery.
- Those who have uninvestigated, gross hematuria.
- Those who have genetic problems including galactose intolerance, Lapp lactase deficiency and glucose-galactose malabsorption.
- Those whose eGFR is < 60 mL/min/1.73 m2.
- Others who are judged ineligible to participate in the trial by the principal investigator (or an authorized trial doctor) due to reasons other than the above inclusion/exclusion criteria.
- Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Research Center, H PLUS Yangji Hospital
Seoul, Gwanakgu, 08779
About this study
Official title: A Randomized, Open-label, Single Dose, Two-way Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR3003" and Co-administration of "BR3003B" and "BR3003C" in Healthy Volunteers.
To perform a comparative evaluation on the pharmacokinetics and the safety after administration of "BR3003" and co-administration of "BR3003B" and "BR3003C" in healthy adults.
Read the detailed description
A randomized, open-label, single oral dose, two-way crossover study under fasting condition. Target number of subjects: 46 subjects in total.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- BR3003(T), BR3003B(R1), BR3003C(R2)
- Keywords
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR3003(T)Drug
Also called Dapagliflozin 10mg / Pioglitazone 30mg
Test drug (T):"BR3003" Boryung Pharmaceutical Co., Ltd.
BR3003B(R1)Drug
Also called Pioglitazone 30mg
Reference drug 1 (R1): "BR3003B" of Celltrion Pharm, Inc.
BR3003C(R2)Drug
Also called Dapagliflozin 10mg
Reference drug 2 (R2): "BR3003C" of AstraZeneca Korea
| Study group | Role | What they receive |
|---|---|---|
| Sequence Group A | Experimental | The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1 and Period 2.
*Sequence A [Period 1] Co-administration of BR3003B(R1) and BR3003C(R2) (single dose)
- Wash out for 7 days [Period 2] Administration of BR3003(T) (single dose) Receives: Drug: BR3003(T); Drug: BR3003B(R1); Drug: BR3003C(R2) |
| Sequence Group B | Experimental | The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1 and Period 2.
*Sequence B [Period 1] Administration of BR3003(T) (single dose)
- Wash out for 7 days [Period 2] Co-administration of BR3003B(R1) and BR3003C(R2) (single dose) Receives: Drug: BR3003(T); Drug: BR3003B(R1); Drug: BR3003C(R2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic variables - AUC
Area under the plasma concentration versus time curve(AUCt) of Pioglitazone and Dapagliflozin(Blood samples are collected 22 times for each Period.)
Measured: Pre-dose(0hour), 0.167hour(10 min), 0.333hour(20 min), 0.5hour(30 minutes), 0.667hour(40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - Cmax
Peak Plasma Concentration(Cmax) of Pioglitazone and Dapagliflozin(Blood samples are collected 22 times for each Period.)
Measured: Pre-dose(0hour), 0.167hour(10 min), 0.333hour(20 min), 0.5hour(30 minutes), 0.667hour(40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Secondary outcomes (10)
Pharmacokinetic variables - AUC∞
AUC∞ of Pioglitazone and Dapagliflozin (Blood samples are collected 22 times for each Period.)
Measured: Pre-dose (0hour), 0.167hour (10min), 0.333hour (20 min), 0.5hour (30 min), 0.667hour (40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - AUCt/AUC∞
AUCt/AUC∞ of Pioglitazone and Dapagliflozin (Blood samples are collected 22 times for each Period.)
Measured: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - Tmax
Tmax of Pioglitazone and Dapagliflozin (Blood samples are collected 22 times for eachour Period.)
Measured: Pre-dose (0hour), 0.167hour (10min), 0.333hour (20 min), 0.5hour (30 min), 0.667hour (40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - t1/2
t1/2 of Pioglitazone and Dapagliflozin (Blood samples are collected 22 times for eachour Period.)
Measured: Pre-dose (0hour), 0.167hour (10min), 0.333hour (20 min), 0.5hour (30 min), 0.667hour (40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - AUCt of Pioglitazone M-IV
AUCt of Pioglitazone M-IV (Blood samples are collected 14 times for eachour Period.)
Measured: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - Cmax of Pioglitazone M-IV
Cmax of Pioglitazone M-IV (Blood samples are collected 14 times for eachour Period.)
Measured: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - AUC∞ of Pioglitazone M-IV
AUC∞ of Pioglitazone M-IV (Blood samples are collected 14 times for eachour Period.)
Measured: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - AUCt/AUC∞ of Pioglitazone M-IV
AUCt/AUC∞ of Pioglitazone M-IV (Blood samples are collected 14 times for eachour Period.)
Measured: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - Tmax of Pioglitazone M-IV
Tmax of Pioglitazone M-IV (Blood samples are collected 14 times for eachour Period.)
Measured: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - t1/2 of Pioglitazone M-IV
t1/2 of Pioglitazone M-IV (Blood samples are collected 14 times for eachour Period.)
Measured: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start28 Apr 2022
- Primary completion3 Jul 2022
- Study completion3 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe 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
- Model description
- two-way crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaewoo Kim, Principal investigator, H Plus Yangji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411965
- Sponsor's protocol ID
- BR-DPC-CT-101
- Status last verified
- Jun 2022
- First submitted
- 26 May 2022
- Last updated
- 27 Jul 2022
- 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 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Two-way Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR3003" and Co-administration of "BR3003B" and "BR3003C" in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT05411965
- Acronym / sponsor ID
- BR-DPC-CT-101
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 3 Jul 2022 (actual)
- Study completion
- 3 Jul 2022 (actual)
- First posted
- 9 Jun 2022 (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.
To perform a comparative evaluation on the pharmacokinetics and the safety after administration of "BR3003" and co-administration of "BR3003B" and "BR3003C" in healthy adults.
Detailed description
A randomized, open-label, single oral dose, two-way crossover study under fasting condition. Target number of subjects: 46 subjects in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two-way crossover
| Arm | Type | Receives |
|---|---|---|
| Sequence Group A | Experimental | Drug: BR3003(T), Drug: BR3003B(R1), Drug: BR3003C(R2)The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1 and Period 2. *Sequence A [Period 1] Co-administration of BR3003B(R1) and BR3003C(R2) (single dose) - Wash out for 7 days [Period 2] Administration of BR3003(T) (single dose) |
| Sequence Group B | Experimental | Drug: BR3003(T), Drug: BR3003B(R1), Drug: BR3003C(R2)The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1 and Period 2. *Sequence B [Period 1] Administration of BR3003(T) (single dose) - Wash out for 7 days [Period 2] Co-administration of BR3003B(R1) and BR3003C(R2) (single dose) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Those who are 19 years old or older at the screening visit.
- Those whose weight is ≥50kg (≥45kg for female subjects) and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2.
- Those without clinically significant congenital or chronic diseases at the screening visit and without any pathological symptom or opinion after an internal medicine examination.
- Those who are judged eligible for the trial by the principal investigator (or an authorized trial doctor) according to diagnostic tests such as hematology test, blood chemistry test, serology test and urinalysis that are predefined according to the characteristics of the investigational drugs in addition to ECG results.
- Those who agree to rule out the possibility of pregnancy through medically acceptable methods of contraception* used by the subject himself/herself or his/her spouse/partner from the first administration of the investigational drugs to 7 days after the last administration of the investigational drugs, and those who agree not to donate their sperms or eggs.
Key exclusion criteria (23 listed)
- Those who currently have or have history of clinically significant diseases related to digestive system, cardiovascular system, endocrine system, respiratory system, hemato-oncology, infection, kidney and genitourinary system, neuropsychiatric system, musculoskeletal system, immune system, Ear-Nose-Throat system, dermal system, ophthalmologic system, etc.
- Those who have medical history of gastrointestinal resection (however, appendectomy and hernia operation shall be excluded) or gastrointestinal system diseases that may influence the absorption of drugs.
- Those who took drugs that substantially induce or inhibit drug-metabolizing enzymes of barbiturates, etc. in 30 days prior to the first administration or who took drugs that can impact the study in 10 days before the first administration. (However, subjects may participate in the study as judged by the principal investigator (or an authorized trial doctor) in consideration of pharmacokinetic or pharmacodynamic characteristics such as the interaction with the investigational drugs and half-life of co-administered drugs.)
- Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational drugs in 180 days prior to the first administration. (The day of the last administration of investigational drugs shall be counted as day 1 of the end of trial.)
- Those who have given a whole blood donation in 60 days prior to the first administration, who have given an apheresis blood donation in 14 days prior to the first administration or who have received blood transfusion in 30 days prior to the first administration.
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 |
|---|---|---|
| BR3003(T)Also: Dapagliflozin 10mg / Pioglitazone 30mgTest drug (T):"BR3003" Boryung Pharmaceutical Co., Ltd. | Drug | Sequence Group A, Sequence Group B |
| BR3003B(R1)Also: Pioglitazone 30mgReference drug 1 (R1): "BR3003B" of Celltrion Pharm, Inc. | Drug | Sequence Group A, Sequence Group B |
| BR3003C(R2)Also: Dapagliflozin 10mgReference drug 2 (R2): "BR3003C" of AstraZeneca Korea | Drug | Sequence Group A, Sequence Group B |
Primary outcome
Pharmacokinetic variables - AUC
Time frame: Pre-dose(0hour), 0.167hour(10 min), 0.333hour(20 min), 0.5hour(30 minutes), 0.667hour(40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Area under the plasma concentration versus time curve(AUCt) of Pioglitazone and Dapagliflozin(Blood samples are collected 22 times for each Period.)
Pharmacokinetic variables - Cmax
Time frame: Pre-dose(0hour), 0.167hour(10 min), 0.333hour(20 min), 0.5hour(30 minutes), 0.667hour(40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Peak Plasma Concentration(Cmax) of Pioglitazone and Dapagliflozin(Blood samples are collected 22 times for each Period.)
10 secondary outcomes
Pharmacokinetic variables - AUC∞
Time frame: Pre-dose (0hour), 0.167hour (10min), 0.333hour (20 min), 0.5hour (30 min), 0.667hour (40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - AUCt/AUC∞
Time frame: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - Tmax
Time frame: Pre-dose (0hour), 0.167hour (10min), 0.333hour (20 min), 0.5hour (30 min), 0.667hour (40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - t1/2
Time frame: Pre-dose (0hour), 0.167hour (10min), 0.333hour (20 min), 0.5hour (30 min), 0.667hour (40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - AUCt of Pioglitazone M-IV
Time frame: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - Cmax of Pioglitazone M-IV
Time frame: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - AUC∞ of Pioglitazone M-IV
Time frame: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - AUCt/AUC∞ of Pioglitazone M-IV
Time frame: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - Tmax of Pioglitazone M-IV
Time frame: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - t1/2 of Pioglitazone M-IV
Time frame: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
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 27 Jul 2022.
- 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.
Jaewoo Kim principal investigator
H Plus Yangji Hospital
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 BR3003(T), BR3003B(R1) and BR3003C(R2) in people with Diabetes Mellitus, Type 2, run by Boryung 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 6 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 27 Jul 2022. 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?
Pharmacokinetic variables - AUC (time frame: Pre-dose(0hour), 0.167hour(10 min), 0.333hour(20 min), 0.5hour(30 minutes), 0.667hour(40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour). 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 27 Jul 2022.