A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- AD-101 45mg
- Conditions
- Osteoporosis
- Sponsor
- Addpharma Inc.
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Peak Plasma Concentration (Cmax)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-101 in healthy volunteers
Detailed Description
This study is to evaluate the pharmacokinetic characteristics and safety of AD-101 compared with administration of raloxifen 60 mg in healthy adults
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy Adult aged 19 and more at the time of screening visit
- •Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit
- •No evidence of medical symptoms or signs of congenital or no chronic disease within the last 3 years as a result of medical examination
Exclusion Criteria
- •Evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, nerve or allergic disease (except for asymptomatic seasonal allergy untreated at the time of administration)
- •History of gastrointestinal disorders (esophageal ataxia or esophageal strictures, Crohn's disease, etc.) or surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of drugs
- •As a result of laboratory tests, the following figures: ALT or AST\> 2 times upper limit of normal range
Arms & Interventions
Raloxifene 60mg to AD-101 45mg
Period 1: Raloxifene 60mg, 1 tab, QD, Per oral / Period 2: AD-101 45mg, 1 tab, QD, Per oral
Intervention: AD-101 45mg
Raloxifene 60mg to AD-101 45mg
Period 1: Raloxifene 60mg, 1 tab, QD, Per oral / Period 2: AD-101 45mg, 1 tab, QD, Per oral
Intervention: Raloxifene 60mg
AD-101 45mg to Raloxifene 60mg
Period 1: AD-101 45mg, 1 tab, QD, Per oral / Period 2: Raloxifene 60mg, 1 tab, QD, Per oral
Intervention: AD-101 45mg
AD-101 45mg to Raloxifene 60mg
Period 1: AD-101 45mg, 1 tab, QD, Per oral / Period 2: Raloxifene 60mg, 1 tab, QD, Per oral
Intervention: Raloxifene 60mg
Outcomes
Primary Outcomes
Peak Plasma Concentration (Cmax)
Time Frame: pre-dose to 96 hours
Cmax of the total ingredient of AD-101
Area under the curve in time plot (AUCt)
Time Frame: pre-dose to 96 hours
AUCt of the total ingredient of AD-101
Secondary Outcomes
- Time to reach Cmax(pre-dose to 96 hours)
- Effective half-life(pre-dose to 96 hours)
- Area under the curve in time plot (AUCinf)(pre-dose to 96 hours)
- Clearance(pre-dose to 96 hours)
- Volume of distribution(pre-dose to 96 hours)