A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-a… (NCT06636877) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-3" and "BR1019-2" in Healthy Volunteers
South Korea52 participantsStarted 2024-10-23
Plain-language summary
The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of "BR1019" and co-administration of "BR1019-3" and "BR1019-2" in healthy volunteers
Who can participate
Age range19 Years
SexALL
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Inclusion Criteria:
* Those have body mass index (BMI) within the range of 18.0 to 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 spontaneously decide to participate and sign written consent to comply with the subject's precautions during the clinical trial period after listening to and fully understanding detailed explanation of this clinical trial
* 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 the first administration of the investigational products to 7 days after the last administration and disagrees 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 prior to the first day of administration or have taken ETC, OTC, Oriental medicine, health functional food concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetic and pharmac…
What they're measuring
1
Area under the concentration-time curve from time zero to time Ï„