A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interactions and Safety Between AD-2111 and AD-2112 in Healthy Adult Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Addpharma Inc.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Area under the curve in time plot (AUCt)
Study Overview
Brief Summary
A phase I clinical trial to evaluate the pharmacokinetic interactions and safety between AD-2111 and AD-2112
Detailed Description
Purpose: pharmacokinetic interactions and safety of AD-2111 and AD-2112 in healthy adult volunteers Condition or disease : Pain Intervention/treatment Drug : AD-2111(Celecoxib 200mg), AD-2112(Tramadol 150mg) Phase : Phase 1
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy Adult aged 19 and more at the time of screening visit
- •Body mass index (BMI) between 18.5 kg/m2 and 27.0 kg/m2 at the time of screening visit
Exclusion Criteria
- •As a result of laboratory tests, the following figures: ALT or AST or total bilirubin > 1.5 times upper limit of normal range
- •As a result of laboratory tests, the following figures: Creatinine clearance < 80mL/min
Arms & Interventions
Treatment A
Period1: Celecoxib 200mg Period2: Tramadol 150mg Period3: Celecoxib 200mg + Tramadol 150mg
Intervention: AD-2111 (Drug)
Treatment A
Period1: Celecoxib 200mg Period2: Tramadol 150mg Period3: Celecoxib 200mg + Tramadol 150mg
Intervention: AD-2112 (Drug)
Treatment B
Period1: Celecoxib 200mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Tramadol 150mg
Intervention: AD-2111 (Drug)
Treatment B
Period1: Celecoxib 200mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Tramadol 150mg
Intervention: AD-2112 (Drug)
Treatment C
Period1: Tramadol 150mg Period2: Celecoxib 200mg Period3: Celecoxib 200mg + Tramadol 150mg
Intervention: AD-2111 (Drug)
Treatment C
Period1: Tramadol 150mg Period2: Celecoxib 200mg Period3: Celecoxib 200mg + Tramadol 150mg
Intervention: AD-2112 (Drug)
Treatment D
Period1: Tramadol 150mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Celecoxib 200mg
Intervention: AD-2111 (Drug)
Treatment D
Period1: Tramadol 150mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Celecoxib 200mg
Intervention: AD-2112 (Drug)
Treatment E
Period1: Celecoxib 200mg + Tramadol 150mg Period2: Celecoxib 200mg Period3: Tramadol 150mg
Intervention: AD-2111 (Drug)
Treatment E
Period1: Celecoxib 200mg + Tramadol 150mg Period2: Celecoxib 200mg Period3: Tramadol 150mg
Intervention: AD-2112 (Drug)
Treatment F
Period1: Celecoxib 200mg + Tramadol 150mg Period2: Tramadol 150mg Period3: Celecoxib 200mg
Intervention: AD-2111 (Drug)
Treatment F
Period1: Celecoxib 200mg + Tramadol 150mg Period2: Tramadol 150mg Period3: Celecoxib 200mg
Intervention: AD-2112 (Drug)
Outcomes
Primary Outcomes
Area under the curve in time plot (AUCt)
Time Frame: pre-dose to 72 hours
AUCt of the total ingredient of Celecoxib, Tramadol
Peak Plasma Concentration (Cmax)
Time Frame: pre-dose to 72 hours
Cmax of the total ingredient of Celecoxib, Tramadol
Secondary Outcomes
- Area under the curve in time plot (AUCinf)(pre-dose to 72 hours)
- Time to reach Cmax(Tmax)(pre-dose to 72 hours)
- Effective half-life(t1/2)(pre-dose to 72 hours)
- Clearance(CL/F)(pre-dose to 72 hours)
- Volume of distribution(Vd/F)(pre-dose to 72 hours)
- Area under the curve in time plot (AUCt) of O-desmethyltramadol(pre-dose to 72 hours)
- Peak Plasma Concentration (Cmax) of O-desmethyltramadol(pre-dose to 72 hours)