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Not yet recruiting NCT07421401

A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015-3 and BR1015-2 Under Fasting Conditions

Phase I Interventional Essential Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BR1015-A, BR1015-3, BR1015-2.
Who it may be relevant to
Registry conditions: Essential Hypertension. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Open-label, Fasting, Oral Administration, Single Dose, 2-sequence, 4-period, Crossover Study to Evaluate the Pharmacokinetics and Safety After Administration of "BR1015-A" and Co-administration of "BR1015-3" and "BR1015-2" in Healthy Adult Volunteers

Overview

The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of BR1015-A and co-administration of BR1015-3 and BR1015-2 in healthy volunteers under fasting conditions

Interventions

  • Drug BR1015-A
    One tablet administered alone
  • Drug BR1015-3
    One tablet administered alone
  • Drug BR1015-2
    One tablet administered alone

Primary outcome measures

  • AUCt of Fimasartan [Time frame: From pre-dose (0 hour) through 48 hours post-dose in each period (Periods 1-4).]
  • AUCt of Indapamide [Time frame: From pre-dose (0 hour) through 72 hours post-dose in each period (Periods 1-2).]
  • Cmax of Fimasartan [Time frame: From pre-dose (0 hour) through 48 hours post-dose in each period (Periods 1-4).]
  • Cmax of Indapamide [Time frame: From pre-dose (0 hour) through 72 hours post-dose in each period (Periods 1-2).]

Eligibility criteria

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 resection or gastrointestinal diseases that may affect the absorption of drugs (except for simple appendectomy or hernia surgery).
  • Subjects who have participated in other clinical trials (including bioequivalence studies) and received investigational products within 6 months prior to the first administration of this study. For this criterion, the 6-month period is counted from the last administration date of the investigational product in the previous study.
  • Subjects who are unable to discontinue consumption of foods that may affect the absorption, distribution, metabolism, or excretion of the investigational product (e.g., raw grapefruit, grapefruit juice, or foods containing grapefruit) from 48 hours prior to the first administration of the investigational product until the collection of the last pharmacokinetic blood sample.
  • Subjects who, for reasons other than those specified in the inclusion and exclusion criteria above, are judged by the principal investigator (or a sub-investigator delegated by the principal investigator) to be unsuitable for participation in the clinical trial.
  • Female subjects who are pregnant, suspected of being pregnant, or currently lactating.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07421401 · BR-FIC-CT-109

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗