Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1017-1" and Co-administration of "BR1017-1A" and "BR1017-1B"
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Conditions:
Essential Hypertension
Primary Hypercholesterolemia
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
The objective of this clinical study is to evaluate the pharmacokinetics and the safety after administration of "BR1017-1" and co-administration of "BR1017-1A" and "BR1017-1B" in healthy volunteers
Eligibility Criteria
Inclusion
- Those who weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit.
- 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.
Exclusion
- 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 drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (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 prior to the first administration date.(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
- Those who have a medical history of gastrointestinal surgery or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
- Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or its products) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration.
- In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
Key Trial Info
Start Date :
December 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2024
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT06184269
Start Date
December 23 2023
End Date
February 18 2024
Last Update
April 2 2024
Active Locations (1)
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1
Clinical Research Center, H PLUS Yangji Hospital
Seoul, Gwanakgu, South Korea, 08779