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An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between Single Oral Administration of BR3006 and Co-administration of BR3006A, BR3006B and BR3006C in Healthy Adult Volunteers

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This was an open-label, randomized, fasting, single-dose, 2-sequence, 2-period crossover study to evaluate the pharmacokinetics and safety between single oral administration of BR3006 and co-administration of BR3006A, BR3006B, and BR3006C in healthy adult volunteers.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: t
View:

• Adults aged over 19 at the time of consent

• Those who are eligible to participate in the clinical trial at the discretion of the principal investigator (or a subinvestigator) through laboratory tests such as hematology tests, blood chemistry tests, serology tests, urine tests, and electrocardiogram (ECG) tests that were planned/performed with specification to the investigational product.

• Those who provided written consent after receiving sufficient explanations and fully understood the objective and details of this clinical trial, the characteristics of the investigational product, and the expected adverse events.

Locations
Other Locations
Republic of Korea
H Plus Yangji Hospital
RECRUITING
Seoul
Contact Information
Primary
Shinyoung Oh
syoh@boryung.co.kr
+82 2-708-8000
Time Frame
Start Date: 2025-07-03
Estimated Completion Date: 2026-07-03
Participants
Target number of participants: 52
Treatments
Experimental: Sequence A (R1+R2+R3 / T)
R1+R2+R3: BR3006A, BR3006B, and BR3006C; T: BR3006
Experimental: Sequence B (T / R1+R2+R3)
T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C
Related Therapeutic Areas
Sponsors
Leads: Boryung Pharmaceutical Co., Ltd

This content was sourced from clinicaltrials.gov

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