A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1018 and Coadmi⦠(NCT06889012) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1018 and Coadministration of BR1018A and BR1018B in Healthy Adult Volunteers
South Korea60 participantsStarted 2025-05-07
Plain-language summary
The purpose of this clinical study is to evaluate the pharmacokinetics and the safety after administration of BR1018 and coadministration of BR1018A and BR1018B in healthy volunteers
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Those who have body mass index (BMI) of more than 18.0kg/m2 and less than 30.0kg/m2 at screening visit.
* For men, Those who weigh 50 kg or more
* For women, Those who weigh 45 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 14 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.
Exclusion Criteria:
* 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 dā¦