Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3180
Source ID: NCT05411965
Associated Drug: Br3003(T)
Title: A Study to Evaluate the Pharmacokinetics After Administration of BR3003 and Co-administration of BR3003B and BR3003C.
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: BR3003(T)|DRUG: BR3003B(R1)|DRUG: BR3003C(R2)
Outcome Measures: Primary: 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: 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|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
Sponsor/Collaborators: Sponsor: Boryung Pharmaceutical Co., Ltd
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 48
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-04-28
Completion Date: 2022-07-03
Results First Posted:
Last Update Posted: 2022-07-27
Locations: Clinical Research Center, H PLUS Yangji Hospital, Seoul, Gwanakgu, 08779, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT05411965