Evaluating the Pharmacokinetic Characteristics of AD-102 in Healthy Volunteers

Addpharma

Status and phase: Completed; Phase 1

Conditions: Osteoporosis

Treatments: Drug: AD-102; Drug: Raloxifene 60mg/Cholecalciferol 800IU

Study type: Interventional

Funder types: Industry

Identifiers

NCT03824171

AD-102BE

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-102 in healthy male subjects

Full description

This study is to evaluate the pharmacokinetic characteristics and safety of AD-102 compared with administration of raloxifen 60 mg + Cholecalciferol 800IU in healthy male subjects

Enrollment: 52 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit
• The Age between 19 and 50 in healthy male volunteers at the time of screening visit

Exclusion criteria

• As a result of laboratory tests, the following figures: ALT or AST> 2 times upper limit of normal range
• As a result of laboratory tests, the following figures: 25-OH vitamin D total <9 ng/mL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

52 participants in 2 patient groups

Raloxifene 60mg/Cholecalciferol 800IU to AD-102

Experimental group

Description:

Period 1: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral

Treatment:

Drug: AD-102

Drug: Raloxifene 60mg/Cholecalciferol 800IU

AD-102 to Raloxifene 60mg/Cholecalciferol 800IU

Experimental group

Description:

Period 1: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral

Treatment:

Drug: AD-102

Drug: Raloxifene 60mg/Cholecalciferol 800IU