A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-1" and "BR1019-2"

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus; Essential Hypertension
• Interventions: Drug: BR1019; Drug: BR1019-1; Drug: BR1019-2

• Registration Number: NCT06226727
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief Summary

The objective of this clinical study is to evaluate the pharmacokinetics and the safety after administration of "BR1019" and co-administration of "BR1019-1" and "BR1019-2" in healthy volunteers

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-01-18
• Study First Posted: 2024-01-26
• Study Start: 2024-02-14
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Those who have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit

  • In case of a male subject, Those who weigh 50 kg or more
  • In case of a female subject, Those who weigh 45 kg or more

• Those who decide to voluntarily participate after listening to and understanding the detailed explanation of this clinical trial and who sign a written consent to comply with the subject's precautions during this clinical trial.

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 ETC, OTC, Oriental medicine, Health functional food 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 bioequivalence tests or other clinical trials 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 gastrectomy(Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
• Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or its products, etc.) 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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence Group A	BR1019-2	The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1\~4. \*Sequence Group A \[Period 1, 3\] Co-administration of BR1019-1(R1) and BR1019-2(R2). \[Period 2, 4\] Administration of BR1019(T)
Sequence Group B	BR1019-2	The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1\~4. \*Sequence Group B \[Period 1, 3\] Administration of BR1019(T) \[Period 2, 4\] Co-administration of BR1019-1(R1) and BR1019-2(R2).
Sequence Group A	BR1019	The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1\~4. \*Sequence Group A \[Period 1, 3\] Co-administration of BR1019-1(R1) and BR1019-2(R2). \[Period 2, 4\] Administration of BR1019(T)
Sequence Group B	BR1019	The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1\~4. \*Sequence Group B \[Period 1, 3\] Administration of BR1019(T) \[Period 2, 4\] Co-administration of BR1019-1(R1) and BR1019-2(R2).
Sequence Group A	BR1019-1	The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1\~4. \*Sequence Group A \[Period 1, 3\] Co-administration of BR1019-1(R1) and BR1019-2(R2). \[Period 2, 4\] Administration of BR1019(T)
Sequence Group B	BR1019-1	The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1\~4. \*Sequence Group B \[Period 1, 3\] Administration of BR1019(T) \[Period 2, 4\] Co-administration of BR1019-1(R1) and BR1019-2(R2).

Primary Outcome Measures

Name	Time	Method
Cmax	0-48 hours after administration	Maximum concentration of drug in plasma
AUCτ	0-48 hours after administration	Area under the concentration-time curve from time zero to time τ

Trial Locations

Locations (1)

Clinical Research Center, H PLUS Yangji Hospital; 🇰🇷 Seoul, Gwanakgu, Korea, Republic of