NCT06931327CompletedPhase 1
To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C711 in Healthy Adults
An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate Bioequivalence of AJU-C711 Compared to C711R in Healthy Adult Volunteers
Source: ClinicalTrials.gov · Last updated 12 Jun 2025
Brief summary (registry, in English)
To evaluate the safety and pharmacokinetic characteristics of AJU-C711 in healthy adults
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 9 Apr 2025
- Start date
- 29 Mar 2025
- Primary completion date
- 16 Apr 2025
- Lead sponsor
- AJU Pharm Co., Ltd.
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT06931327
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 60
- From 29 Mar 2025 to the primary completion date, 16 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
- Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month or the first administration of clinical trial drug within 10 days
- Those who donated whole blood within 8 weeks, received apheresis within 2 weeks, blood transfusion within 1 month or can't refrain from donating blood from the time of written consent until the end of the study
Other illness
- Those who has a history of gastrointestinal disease or surgery which may affect the absorption of the drug
- Those who has a history of mental illness
Lab values
- Those who has under
- Those who are hypersensitive to component of the Investigational product and have the medical history
- Those with active liver disease or persistent elevation of aminotransferase levels of unknown
- Those with severe hepatic impairment or biliary atresia and cholestasis
- Those taking cyclosporin
- Those with myopathy
- Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, dihydropyridine sensitivity, angioedema
- Those who has Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
Other
- Those who exceeding an alcohol consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, liquor: 30mL or Beer 250mL)
- Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons
- Women who are pregnant or who may be pregnant and breastfeed
Who the study is looking for
- Healthy adult volunteers aged ≥ 19-year-old
- Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
- Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
- Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
- 6\. Those who agree to contraception during the participation of clinical trial 7. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial
Age in the registry: 19 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bumin Hospital, Seoul, Republic of South Korea Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.