A Study to Evaluate the Pharmacokinetics and Safety Between Single Administration of "BR6002" and Coadministration of "BR6002A" and "BR6002B" Under Fasting Conditions in Healthy Adult Volunteers
NCT ID: NCT05959486
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2023-07-14
2023-08-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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BR6002A+BR6002B
BR6002A
One tablet administered alone
BR6002B
One tablet administered alone
BR6002
BR6002
One capsule administered alone
Interventions
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BR6002A
One tablet administered alone
BR6002B
One tablet administered alone
BR6002
One capsule administered alone
Eligibility Criteria
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Inclusion Criteria
* Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception (In the case of a female subject, hormone drugs is excluded) accepted in clinical trial 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, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.
* 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
\& genitourinary system, neuropsychiatric system, musculoskeletal system, immune system, ENT system, skin system, ophthalmic system.
* Those who have a medical history of gastrointestinal surgery (Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 1 month prior to the first day of administration or have taken ETC, OTC, herbal medicine and health functional foods 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)
* Those who have participated in other clinical trials or bioequivalence tests and administered their investigational products within 6 months prior to the first administration date.
* In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
19 Years
55 Years
ALL
Yes
Sponsors
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Boryung Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Clinical Research Center, H PLUS Yangji Hospital
Seoul, Gwanakgu, South Korea
Countries
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Other Identifiers
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BR-ARC-CT-102
Identifier Type: -
Identifier Source: org_study_id