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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.
A randomized, open-label, single oral dose, two-way crossover study under fasting condition. Target number of subjects: 46 subjects in total.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR3003(T) | Drug | Test drug (T):"BR3003" Boryung Pharmaceutical Co., Ltd. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables - AUC∞ | AUC∞ of Pioglitazone and Dapagliflozin (Blood samples are collected 22 times for each Period.) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
Others who are judged ineligible to participate in the trial by the principal investigator (or an authorized trial doctor) due to reasons other than the above inclusion/exclusion criteria.
Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.
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| Name | Affiliation | Role |
|---|---|---|
| Jaewoo Kim | H Plus Yangji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, H PLUS Yangji Hospital | Seoul | Gwanakgu | 08779 | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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two-way crossover
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| BR3003B(R1) | Drug | Reference drug 1 (R1): "BR3003B" of Celltrion Pharm, Inc. |
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| BR3003C(R2) | Drug | Reference drug 2 (R2): "BR3003C" of AstraZeneca Korea |
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| Pharmacokinetic variables - AUCt/AUC∞ | AUCt/AUC∞ of Pioglitazone and Dapagliflozin (Blood samples are collected 22 times for each Period.) | Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour |
| Pharmacokinetic variables - Tmax | Tmax of Pioglitazone and Dapagliflozin (Blood samples are collected 22 times for eachour Period.) | 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 | t1/2 of Pioglitazone and Dapagliflozin (Blood samples are collected 22 times for eachour Period.) | 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 | AUCt of Pioglitazone M-IV (Blood samples are collected 14 times for eachour Period.) | Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour |
| Pharmacokinetic variables - Cmax of Pioglitazone M-IV | Cmax of Pioglitazone M-IV (Blood samples are collected 14 times for eachour Period.) | Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour |
| Pharmacokinetic variables - AUC∞ of Pioglitazone M-IV | AUC∞ of Pioglitazone M-IV (Blood samples are collected 14 times for eachour Period.) | Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour |
| Pharmacokinetic variables - AUCt/AUC∞ of Pioglitazone M-IV | AUCt/AUC∞ of Pioglitazone M-IV (Blood samples are collected 14 times for eachour Period.) | Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour |
| Pharmacokinetic variables - Tmax of Pioglitazone M-IV | Tmax of Pioglitazone M-IV (Blood samples are collected 14 times for eachour Period.) | Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour |
| Pharmacokinetic variables - t1/2 of Pioglitazone M-IV | t1/2 of Pioglitazone M-IV (Blood samples are collected 14 times for eachour Period.) | Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |