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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06184269
Other study ID # BR-FAEC-CT-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 23, 2023
Est. completion date February 18, 2024

Study information

Verified date April 2024
Source Boryung Pharmaceutical Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date February 18, 2024
Est. primary completion date February 18, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - 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 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 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.

Study Design


Intervention

Drug:
BR1017-1
One tablet administered alone
BR1017-1A
One tablet administered alone
BR1017-1B
One tablet administered alone

Locations

Country Name City State
Korea, Republic of Clinical Research Center, H PLUS Yangji Hospital Seoul Gwanakgu

Sponsors (1)

Lead Sponsor Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary AUCt Area under the concentration-time curve from time zero to time t 0-72 hours after administration
Primary Cmax Maximum concentration of drug in plasma 0-72 hours after administration
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