A Study to Evaluate the Pharmacokinetics After Administration of BR3003 and Co-administration of BR3003B and BR3003C.

NCT ID: NCT05411965

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-28
• Study Completion Date: 2022-07-03

Brief Summary

To perform a comparative evaluation on the pharmacokinetics and the safety after administration of "BR3003" and co-administration of "BR3003B" and "BR3003C" in healthy adults.

Detailed Description

A randomized, open-label, single oral dose, two-way crossover study under fasting condition. Target number of subjects: 46 subjects in total.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequence Group A

The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1 and Period 2.

*Sequence A [Period 1] Co-administration of BR3003B(R1) and BR3003C(R2) (single dose)

• Wash out for 7 days [Period 2] Administration of BR3003(T) (single dose)

Group Type: EXPERIMENTAL

BR3003(T)

Intervention Type: DRUG

Test drug (T):"BR3003" Boryung Pharmaceutical Co., Ltd.

BR3003B(R1)

Intervention Type: DRUG

Reference drug 1 (R1): "BR3003B" of Celltrion Pharm, Inc.

BR3003C(R2)

Intervention Type: DRUG

Reference drug 2 (R2): "BR3003C" of AstraZeneca Korea

Sequence Group B

The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1 and Period 2.

*Sequence B [Period 1] Administration of BR3003(T) (single dose)

• Wash out for 7 days [Period 2] Co-administration of BR3003B(R1) and BR3003C(R2) (single dose)

Group Type: EXPERIMENTAL

BR3003(T)

Intervention Type: DRUG

Test drug (T):"BR3003" Boryung Pharmaceutical Co., Ltd.

BR3003B(R1)

Intervention Type: DRUG

Reference drug 1 (R1): "BR3003B" of Celltrion Pharm, Inc.

BR3003C(R2)

Intervention Type: DRUG

Reference drug 2 (R2): "BR3003C" of AstraZeneca Korea

Interventions

BR3003(T)

Test drug (T):"BR3003" Boryung Pharmaceutical Co., Ltd.

Intervention Type: DRUG

BR3003B(R1)

Reference drug 1 (R1): "BR3003B" of Celltrion Pharm, Inc.

Intervention Type: DRUG

BR3003C(R2)

Reference drug 2 (R2): "BR3003C" of AstraZeneca Korea

Intervention Type: DRUG

Other Intervention Names

Dapagliflozin 10mg / Pioglitazone 30mg; Pioglitazone 30mg; Dapagliflozin 10mg

Eligibility Criteria

Inclusion Criteria

1. Those who are 19 years old or older at the screening visit.

2. Those whose weight is ≥50kg (≥45kg for female subjects) and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2.

3. Those without clinically significant congenital or chronic diseases at the screening visit and without any pathological symptom or opinion after an internal medicine examination.

4. Those who are judged eligible for the trial by the principal investigator (or an authorized trial doctor) according to diagnostic tests such as hematology test, blood chemistry test, serology test and urinalysis that are predefined according to the characteristics of the investigational drugs in addition to ECG results.

5. Those who agree to rule out the possibility of pregnancy through medically acceptable methods of contraception* used by the subject himself/herself or his/her spouse/partner from the first administration of the investigational drugs to 7 days after the last administration of the investigational drugs, and those who agree not to donate their sperms or eggs.

6. Those who are given detailed explanations about the trial objectives, components as well as the properties of the investigational drugs and express their voluntary consent to participate in the trial by signing a written consent.

Exclusion Criteria

1. Those who currently have or have history of clinically significant diseases related to digestive system, cardiovascular system, endocrine system, respiratory system, hemato-oncology, infection, kidney and genitourinary system, neuropsychiatric system, musculoskeletal system, immune system, Ear-Nose-Throat system, dermal system, ophthalmologic system, etc.

2. Those who have medical history of gastrointestinal resection (however, appendectomy and hernia operation shall be excluded) or gastrointestinal system diseases that may influence the absorption of drugs.

3. Those who took drugs that substantially induce or inhibit drug-metabolizing enzymes of barbiturates, etc. in 30 days prior to the first administration or who took drugs that can impact the study in 10 days before the first administration. (However, subjects may participate in the study as judged by the principal investigator (or an authorized trial doctor) in consideration of pharmacokinetic or pharmacodynamic characteristics such as the interaction with the investigational drugs and half-life of co-administered drugs.)

4. Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational drugs in 180 days prior to the first administration. (The day of the last administration of investigational drugs shall be counted as day 1 of the end of trial.)

5. Those who have given a whole blood donation in 60 days prior to the first administration, who have given an apheresis blood donation in 14 days prior to the first administration or who have received blood transfusion in 30 days prior to the first administration.

6. Those who are applicable to the following conditions in 30 days prior to the first administration:

• Male subjects: average alcohol intake > 21 units/week
• Female subjects: average alcohol intake > 14 units/week

(1 unit= 50 mL of soju, 30 mL of hard liquor or 250 mL of beer)

• Daily average smoking of >20 cigarettes

7. Those who apply to the following criteria

• Those who have medical history of hypersensitivity to major ingredients, other ingredients or additives of the investigational drugs.
• Those who have diabetic ketoacidosis, diabetic coma and precoma or type 1 diabetes.
• Those who are under dialysis.
• Those who currently have or have medical history of heart failure.
• Those who have active bladder cancer or have history of bladder cancer.
• Those who have hepatopathy or severe renal impairment.
• Those who have severe infection or severe trauma before or after surgery.
• Those who have uninvestigated, gross hematuria.
• Those who have genetic problems including galactose intolerance, Lapp lactase deficiency and glucose-galactose malabsorption.
• Those whose eGFR is < 60 mL/min/1.73 m2.

9. Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaewoo Kim

Role: PRINCIPAL_INVESTIGATOR

H Plus Yangji Hospital

Locations

Clinical Research Center, H PLUS Yangji Hospital

Seoul, Gwanakgu, South Korea

Countries

South Korea

Other Identifiers

BR-DPC-CT-101

Identifier Type: -

Identifier Source: org_study_id