Study to Evaluate Pharmacokinetic and Pharmacodynamic Drug Interactions and Safety of IY-HCR21 and IY-MIC
NCT Number: NCT06471868
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pharmacokinetics
Interventions: DRUG: IY-HCR21|DRUG: IY-MIC
Sponsor: Il-Yang Pharm. Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2024-07-02
Locations: H plus Yangji Hospital, Seoul, Gwanak-gu, 08756, Korea, Republic of

Summary:
This study evaluate the pharmacokinetic and safety of IY-HCR21

Primary Outcome Measures: Betanechol AUCt,ss, Betanechol AUCt,ss(Area under the plasma drug concentration-time curve in steady state), Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)|Betanechol Cmax,ss, Betanechol Cmax,ss (Maximum plasma concentration in steady state), Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)
Secondary Outcome Measures: AUCinf, Betanechol AUCinf(Area under the plasma drug concentration-time curve from time 0 to infinity), Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)|t1/2, Betanechol t1/2(Terminal half-life), Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)|Tmax,ss, Betanechol Tmax,ss(Time to maximum plasma concentration in steady state), Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)|AUCt/AUCinf, Betanechol AUCt/AUCinf, Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)|AUC24, Betanechol AUC24 (Area Under the Plasma Concentration-Time curve in 24hour), Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24)|Cmin,ss, Betanechol Cmin,ss (Minimum plasma concentration in steady state), Day 1 : Predose(0 hour), Day 2 : Predose(0 hour) Day 3 : Predose(0 hour), Afterdose (0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 16.5, 17, 18, 18.5, 19, 19.5, 20, 20.5, 21, 22, 24, 36, 48)