A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-a… (NCT07421388) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015-1 and BR1015-2 Under Fed Conditions
48 participantsStarted 2026-04-09
Plain-language summary
The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of BR1015-A and co-administration of BR1015-1 and BR1015-2 in healthy volunteers under fed conditions
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:
* Subjects with a body mass index (BMI) of more than 18.0 kg/m² and less than 30.0 kg/m² at the screening visit.
* Subjects who provide written informed consent voluntarily after receiving and understanding sufficient explanation regarding the purpose and procedures of the clinical trial, the characteristics of the investigational product, and the expected adverse events.
* Subjects who agree to use a highly effective method of contraception, excluding hormonal contraceptives, from the time of signing the written informed consent form until 14 days after the last administration of the investigational product, and who agree not to donate sperm or ova during this period. This requirement applies to the subject and, as applicable, to their spouse or sexual partner in order to prevent pregnancy.
Exclusion Criteria:
* Subjects who have taken drugs that induce or inhibit metabolizing enzymes, such as barbiturates, within 30 days prior to the first administration of the investigational product, or who have taken any prescription drugs, over-the-counter drugs (OTC), herbal medicines, or dietary supplements within 10 days prior to the first administration that may interfere with the conduct of the study (however, participation may be allowed considering the pharmacokinetics and pharmacodynamics, including potential interactions with the investigational product and the half-life of concomitant drugs).
* Subjects with a medical history of gastrointestinal resectio…
What they're measuring
1
AUCt of Fimasartan
Timeframe: From pre-dose (0 hour) through 48 hours post-dose in each period (Periods 1-4).
2
AUCt of Indapamide
Timeframe: From pre-dose (0 hour) through 72 hours post-dose in each period (Periods 1-2).
3
Cmax of Fimasartan
Timeframe: From pre-dose (0 hour) through 48 hours post-dose in each period (Periods 1-4).
4
Cmax of Indapamide
Timeframe: From pre-dose (0 hour) through 72 hours post-dose in each period (Periods 1-2).