HealthyPhase 1NCT04325009
Bioequivalence Study Between "Dong-A Atorvastatin Tab" and "Lipitor Tab"
A Phase 1 study testing Lipitor 80mg Tab → Dong-A Atorvastatin 80mg Tab and Dong-A Atorvastatin 80mg Tab → Lipitor 80mg Tab in people with Healthy, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
An Open-Label, Randomized, 2-sequence, 4-period, Fasting Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence between "Dong-A Atorvastatin 80mg Tab" and "Lipitor 80mg Tab" in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lipitor 80mg Tab → Dong-A Atorvastatin 80mg Tab and Dong-A Atorvastatin 80mg Tab → Lipitor 80mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Mar 2020to Aug 2020
- 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
- A person who aged 19 or older at the time of screening
- BMI of 18 to 30 (BMI calculation: kg/m2)
- Males weighing 50kg or more
- Females weighing 45kg or more
- No congenital or chronic diseases or pathological symptoms
- A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination
- A person who has fully understood the contents of the consent form for the study and signed the consent form voluntarily and recorded the date of signature
- A person who agreed to use contraception from the first administration of IP to a week after the last administration of IP
Who cannot join
- A person who has taken a drug that significantly induces (e.g., barbital) or inhibits the drug metabolic enzyme within 30 days prior to the first administration of IP
- A person who has participated in other clinical trials within six months prior to the first administration of the IP
- A person who has had whole blood transfusion within 2 months or the apheresis within 2 weeks before the first administration of IP
- A person who has medical history of gastric resection that can affect the drug absorption
- A person with a history of regular alcohol intake within a month prior to the first administration of the IP:
- Male: More than 21 cups/week
Show all 11Show fewer
- Female: More than 14 cups/week (1 cup: 50 ml of soju, 250 ml of beer, 30ml of spirits)
- A person who is hypersensitive to any of the IP components, taking glecaprevir, pibrentasvir, has active hepatic disease, Blood AST (GOT) or ALT (GPT) levels exceed the upper reference range limit by 3 times, muscle disease, or any genetic symtoms such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- A person who has medical history of mental disease
- A person who is judged not to be suitable for the study by the investigator
- Lactating or possibly pregnant women
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
H Plus Yangji Hospital
Seoul, 08779
SeungHyun Kang, 82-070-4665-9490, juspa@naver.com
About this study
Official title: A Open-Label, Randomized, 2-sequence, 4-period, Fasting Condition, Singledose, Per Oral, Cross-over Study to Evaluate the Bioequivalence Between "Dong-A Atorvastatin 80mg Tab" and "Lipitor 80mg Tab" in Healthy Volunteers
An Open-Label, Randomized, 2-sequence, 4-period, Fasting Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence between "Dong-A Atorvastatin 80mg Tab" and "Lipitor 80mg Tab" in Healthy Volunteers
Read the detailed description
- Study design: An open-Label, randomized, 2-sequence, 4-period, fasting condition, single-dose, per oral, cross-over study
- Administration method: The subject should maintain a minimum of 10 hours of empty stomach before administration, and give an oral dose of 1 tablets (Dong-A Atorvastatin 80mg or Lipitor 80mg) with 150 mL of water at around 8 a.m. on the day of the test. The subject should not chew or break the drug, but should swallow in whole with water. The difference in administration time between the test subjects is about one minute apart, considering the blood collection time.
- Wash out period: at least 7 days
- Blood collection time: Before the administration, 0.17, 0.33, 0.5, 0.75, 1, 1.33, 1.67, 2, 3, 4, 6, 8, 12, 24, 36 hr after the administration (total 16 times)
- Analysis: Measurement of the concentration of an unchangeable substance of Atorvastatin in plasma
- Conditions
- Healthy
- Being tested
- Lipitor 80mg Tab → Dong-A Atorvastatin 80mg Tab, Dong-A Atorvastatin 80mg Tab → Lipitor 80mg Tab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipitor 80mg Tab → Dong-A Atorvastatin 80mg TabDrug
- st period: single oral administration of 1 tablet of "Lipitor 80mg Tab" washout period: 7days
- nd period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab" washout period: 7days
- rd period: single oral administration of 1 tablet of "Lipitor 80mg Tab" washout period: 7days
- th period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab"
Dong-A Atorvastatin 80mg Tab → Lipitor 80mg TabDrug
- st period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab" washout period: 7days
- nd period: single oral administration of 1 tablet of "Lipitor 80mg Tab" washout period: 7days
- rd period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab" washout period: 7days
- th period: single oral administration of 1 tablet of "Lipitor 80mg Tab"
| Study group | Role | What they receive |
|---|---|---|
| RTRT | Experimental | R: "Lipitor 80mg Tab" T: "Dong-A Atorvastatin 80mg Tab" Receives: Drug: Lipitor 80mg Tab → Dong-A Atorvastatin 80mg Tab |
| TRTR | Experimental | R: "Lipitor 80mg Tab" T: "Dong-A Atorvastatin 80mg Tab" Receives: Drug: Dong-A Atorvastatin 80mg Tab → Lipitor 80mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the plasma Concetration versus time curve(AUCt) of Atorvastatin
Area Under the plasma Concetration versus time curve(AUCt) of Atorvastatin
Measured: Before administration ~ 36hrs
Peak Plasma Concentration(Cmax) of Atorvastatin
Peak Plasma Concentration(Cmax) of Atorvastatin
Measured: Before administration ~ 36hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start30 Mar 2020 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionAug 2020 (estimated)
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment single-dose, 2-sequence, 4-period Bioequivalence Study
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SeungHyun Kang, Ph.D, Principal investigator, H Plus Yangji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325009
- Sponsor's protocol ID
- DDS19-066BE
- Status last verified
- Mar 2020
- First submitted
- 25 Mar 2020
- Last updated
- 27 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open-Label, Randomized, 2-sequence, 4-period, Fasting Condition, Singledose, Per Oral, Cross-over Study to Evaluate the Bioequivalence Between "Dong-A Atorvastatin 80mg Tab" and "Lipitor 80mg Tab" in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04325009
- Acronym / sponsor ID
- DDS19-066BE
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2020 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 27 Mar 2020 (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.
An Open-Label, Randomized, 2-sequence, 4-period, Fasting Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence between "Dong-A Atorvastatin 80mg Tab" and "Lipitor 80mg Tab" in Healthy Volunteers
Detailed description
- Study design: An open-Label, randomized, 2-sequence, 4-period, fasting condition, single-dose, per oral, cross-over study
- Administration method: The subject should maintain a minimum of 10 hours of empty stomach before administration, and give an oral dose of 1 tablets (Dong-A Atorvastatin 80mg or Lipitor 80mg) with 150 mL of water at around 8 a.m. on the day of the test. The subject should not chew or break the drug, but should swallow in whole with water. The difference in administration time between the test subjects is about one minute apart, considering the blood collection time.
- Wash out period: at least 7 days
- Blood collection time: Before the administration, 0.17, 0.33, 0.5, 0.75, 1, 1.33, 1.67, 2, 3, 4, 6, 8, 12, 24, 36 hr after the administration (total 16 times)
- Analysis: Measurement of the concentration of an unchangeable substance of Atorvastatin in plasma
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover Assignment single-dose, 2-sequence, 4-period Bioequivalence Study
| Arm | Type | Receives |
|---|---|---|
| RTRT | Experimental | Drug: Lipitor 80mg Tab → Dong-A Atorvastatin 80mg TabR: "Lipitor 80mg Tab" T: "Dong-A Atorvastatin 80mg Tab" |
| TRTR | Experimental | Drug: Dong-A Atorvastatin 80mg Tab → Lipitor 80mg TabR: "Lipitor 80mg Tab" T: "Dong-A Atorvastatin 80mg Tab" |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A person who aged 19 or older at the time of screening
- BMI of 18 to 30 (BMI calculation: kg/m2)
- No congenital or chronic diseases or pathological symptoms
- A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination
- A person who has fully understood the contents of the consent form for the study and signed the consent form voluntarily and recorded the date of signature
Key exclusion criteria (11 listed)
- A person who has taken a drug that significantly induces (e.g., barbital) or inhibits the drug metabolic enzyme within 30 days prior to the first administration of IP
- A person who has participated in other clinical trials within six months prior to the first administration of the IP
- A person who has had whole blood transfusion within 2 months or the apheresis within 2 weeks before the first administration of IP
- A person who has medical history of gastric resection that can affect the drug absorption
- A person with a history of regular alcohol intake within a month prior to the first administration of the IP:
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 |
|---|---|---|
| Lipitor 80mg Tab → Dong-A Atorvastatin 80mg Tab1. st period: single oral administration of 1 tablet of "Lipitor 80mg Tab" washout period: 7days 2. nd period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab" washout period: 7days 3. rd period: single oral administration of 1 tablet of "Lipitor 80mg Tab" washout period: 7days 4. th period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab" | Drug | RTRT |
| Dong-A Atorvastatin 80mg Tab → Lipitor 80mg Tab1. st period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab" washout period: 7days 2. nd period: single oral administration of 1 tablet of "Lipitor 80mg Tab" washout period: 7days 3. rd period: single oral administration of 1 tablet of "Dong-A Atorvastatin 80mg Tab" washout period: 7days 4. th period: single oral administration of 1 tablet of "Lipitor 80mg Tab" | Drug | TRTR |
Primary outcome
Area Under the plasma Concetration versus time curve(AUCt) of Atorvastatin
Time frame: Before administration ~ 36hrs
Area Under the plasma Concetration versus time curve(AUCt) of Atorvastatin
Peak Plasma Concentration(Cmax) of Atorvastatin
Time frame: Before administration ~ 36hrs
Peak Plasma Concentration(Cmax) of Atorvastatin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
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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.
SeungHyun Kang, Ph.D 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 Lipitor 80mg Tab → Dong-A Atorvastatin 80mg Tab and Dong-A Atorvastatin 80mg Tab → Lipitor 80mg Tab in people with Healthy, run by Dong-A ST 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 8 inclusion and 11 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 27 Mar 2020. 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?
Contact SeungHyun Kang, Ph.D (82-070-4665-9490, juspa@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the plasma Concetration versus time curve(AUCt) of Atorvastatin (time frame: Before administration ~ 36hrs). 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 Mar 2020.