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

NCT05411965 | Completed Phase 1

• 1 other identifier: BR-DPC-CT-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic variables - AUC

  Area under the plasma concentration versus time curve(AUCt) of Pioglitazone and Dapagliflozin(Blood samples are collected 22 times for each Period.)

  Pre-dose(0hour), 0.167hour(10 min), 0.333hour(20 min), 0.5hour(30 minutes), 0.667hour(40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour

• Pharmacokinetic variables - Cmax

  Peak Plasma Concentration(Cmax) of Pioglitazone and Dapagliflozin(Blood samples are collected 22 times for each Period.)

  Pre-dose(0hour), 0.167hour(10 min), 0.333hour(20 min), 0.5hour(30 minutes), 0.667hour(40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour

Secondary Outcomes (10)

• Pharmacokinetic variables - AUC∞

  Pre-dose (0hour), 0.167hour (10min), 0.333hour (20 min), 0.5hour (30 min), 0.667hour (40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour

• Pharmacokinetic variables - AUCt/AUC∞

  Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour

• Pharmacokinetic variables - Tmax

  Pre-dose (0hour), 0.167hour (10min), 0.333hour (20 min), 0.5hour (30 min), 0.667hour (40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour

• Pharmacokinetic variables - t1/2

  Pre-dose (0hour), 0.167hour (10min), 0.333hour (20 min), 0.5hour (30 min), 0.667hour (40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour

• Pharmacokinetic variables - AUCt of Pioglitazone M-IV

  Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour

Study Arms (2)

Sequence Group A

EXPERIMENTAL

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)

Drug: BR3003(T); Drug: BR3003B(R1); Drug: BR3003C(R2)

Sequence Group B

EXPERIMENTAL

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)

Drug: BR3003(T); Drug: BR3003B(R1); Drug: BR3003C(R2)

Interventions

BR3003(T) DRUG

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

Also known as: Dapagliflozin 10mg / Pioglitazone 30mg

Sequence Group A; Sequence Group B

BR3003B(R1) DRUG

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

Also known as: Pioglitazone 30mg

Sequence Group A; Sequence Group B

BR3003C(R2) DRUG

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

Also known as: Dapagliflozin 10mg

Sequence Group A; Sequence Group B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who are 19 years old or older at the screening visit.
• 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.
• Those without clinically significant congenital or chronic diseases at the screening visit and without any pathological symptom or opinion after an internal medicine examination.
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.)
• 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.)
• 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.
• 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
• 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.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Clinical Research Center, H PLUS Yangji Hospital

Seoul, Gwanakgu, 08779, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

dapagliflozin; Pioglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jaewoo Kim

  H Plus Yangji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: two-way crossover

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 9, 2022
• Study Start: April 28, 2022
• Primary Completion: July 3, 2022
• Study Completion: July 3, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)