Evaluating the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers

Addpharma

Status and phase: Completed; Phase 1

Conditions: Osteoporosis

Treatments: Drug: Raloxifene 60mg; Drug: AD-101 45mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03764462

AD-101BE

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-101 in healthy volunteers

Full description

This study is to evaluate the pharmacokinetic characteristics and safety of AD-101 compared with administration of raloxifen 60 mg in healthy adults

Enrollment: 52 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Raloxifene 60mg to AD-101 45mg

Experimental group

Description:

Period 1: Raloxifene 60mg, 1 tab, QD, Per oral / Period 2: AD-101 45mg, 1 tab, QD, Per oral

Treatment:

Drug: AD-101 45mg

Drug: Raloxifene 60mg

AD-101 45mg to Raloxifene 60mg

Experimental group

Description:

Period 1: AD-101 45mg, 1 tab, QD, Per oral / Period 2: Raloxifene 60mg, 1 tab, QD, Per oral

Treatment:

Drug: AD-101 45mg

Drug: Raloxifene 60mg