New drug vs old drug: which one works better?
NCT ID NCT07311811
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two drugs, IN-M00007 and IN-R00007, to see if they are equivalent in healthy adults aged 19 to 59. Sixty volunteers will take a single dose of each drug in random order, and researchers will measure how the drugs are absorbed and how safe they are. The goal is to check if the new drug can be used as a substitute for the existing one.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rosuvastatin and Ezetimibe combination
- What this could lead to
- If successful, this could confirm that the new drug works the same as the existing one, potentially offering a generic alternative.
- What could go wrong
- This is an early phase 1 trial in only 60 healthy people, so results may not apply to patients. The study is not yet recruiting.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 59 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Healthy adult volunteers aged ≥ 19 and \< 60 years at screening 2. Body mass index(BMI) in the range of 18.0 and 30.0 kg/㎡ * Body weight ≥ 50kg for male * Body weight ≥ 45kg for female 3. Subjects who do not have significant congenital or chronic diseases and without pathological symptoms or findings based on medical examinations(if necessary, EEG, ECG, chest X-ray, gastroscopy or gastrointestinal radiographic tests) 4. Determined by the investigator to be eligible for study participation based on the results of screening tests (e.g. hematology test, blood chemistry test, serology test, urinalysis, pregnancy diagnostic tests) conducted according to the IP characteristics 5. Subjects who voluntarily signed the consent form after receiving detailed explanation and understanding about purpose, details, characteristics of the IP and anticipated adverse events of the study 6. Subjects who agree to use highly effective methods of contraception(excluding hormonal methods) to preclude the possibility of pregnancy of themselves or their spouse/partner from the first IP administration until 14 days after the last administration, and who agrees not to donate sperm or ovum during this period * Highly effective contraceptive methods: intrauterine device(IUD), bilateral tubal ligation, a partner who has undergone vasectomy, or sexual abstinence However, periodic abstinence(calendar method, symptothermal method, post-ovulation method), withdrawal intercourse(coitus interruptus), spermicide methods, lactational amenorrhea method, and simultaneous use of female and male condoms are not considered contraceptive methods Exclusion Criteria: 1. Subjects who have taken drugs which can induce(e.g, Barbiturates) or inhibit drug metabolism enzyme within 30 days prior to the start of the study(first IP administration day) or have taken medications that may affect this study within 10 days prior to the start of the study(first IP administration day) 2. Subjects who have participated in any other clinical study or bioequivalence study and administered IP within 6 months 3. Subjects who have donated whole blood within 8 weeks prior to the start of the study(first IP administration day) or have donated component blood within 2 weeks prior to the start of the study(first IP administration day) 4. Subjects with a history of gastrointestinal resection that may affect drug absorption(excluding appendectomy and hernia operation) 5. Subjects meeting following conditions within 1 month prior to the start of the study(first IP administration day) * Alcohol consumption \> 21 glasses per week for male * Alcohol consumption \> 14 glasses per week for female 6. Subjects with the following diseases * Subjects with hypersensitivity to the ingredient or components of this drug * Subjects with active liver disease or those with persistently elevated serum aminotransferase levels of unknown cause * Subjects with muscular disorders * Subjects receiving concomitant administration with cyclosporine * Subjects with severe renal impairment or kidney dysfunction * Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 7. Subjects with a clinically significant history of mental illness 8. Pregnant or breastfeeding women if female 9. Subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion/exclusion criteria
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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H PLUS Yangji Hospital, Clinical Trial Center
Seoul, South Korea
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