NCT06879158CompletedPhase 1
A Study to Evaluate the Pharmacokinetics and Safety of BR3409 and Co-administration of BR3409-1 and BR3409-2 in Healthy Volunteers Under Fasting Conditions
A Randomized, Open-label, Fasting, Single Dose, Two-way Crossover Study to Evaluate the Pharmacokinetics and Safety of BR3409 and Co-administration of BR3409-1 and BR3409-2 in Healthy Volunteers
Source: ClinicalTrials.gov · Last updated 17 Mar 2025
Brief summary (registry, in English)
The purpose of this clinical study is to evaluate the pharmacokinetics and safety of BR3409 and co-administration of BR3409-1 and BR3409-2 in healthy volunteers Under Fasting Conditions
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 11 Mar 2025
- Start date
- 10 Nov 2024
- Primary completion date
- 26 Jan 2025
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Diseases
- Type 2 diabetes
- NCT number
- NCT06879158
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 50
- From 10 Nov 2024 to the primary completion date, 26 Jan 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 have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days before the first administration date or have taken drugs concerned about affecting this clinical trial within 10 days before the first administration date. (However, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
- Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months before the first day of administration. (However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
Other illness
- Those who have a medical history of gastrointestinal resection or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
Other
- In the case of a female subject, those suspected pregnancy or pregnant woman, lactating woman.
Who the study is looking for
- Those have body mass index (BMI: weight(kg)/the square of {height(m)}) within the range of 18.0 to 30.0 at screening visit.
- For men, Those who weigh 55 kg or more
- For women, Those who weigh 50 kg or more
- Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.
- Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\*(Except for hormone drugs) from the date of consent to 56 days after the last administration and disagree to provide their sperm or ovum.
- Methods of contraception accepted in clinical trial: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.
Age in the registry: 19 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Research Center, H PLUS Yangji Hospital 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.