Evaluating the Pharmacokinetic Characteristics of AD-102 in Healthy Volunteers

Osteoporosis Clinical Trial

Official title:

A Randomized, Open Label, Single Dose, Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of AD-102 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824171
• Other study ID #: AD-102BE
• Status: Completed
• Phase: Phase 1
• Start date: February 28, 2019
• Est. completion date: April 8, 2019

Study information

• Verified date: August 2019
• Source: Addpharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 8, 2019
• Est. primary completion date: March 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Raloxifene 60mg/Cholecalciferol 800IU
Raloxifene 60mg/Cholecalciferol 800IU tablet
• AD-102
AD-102 Raloxefene 45mg/Cholecalciferol 800IU tablet

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hosptial	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with adverse events	Incidence rate of adverse events	From Day 1 until 32 Days
Primary	Peak Plasma Concentration (Cmax)	Cmax of Raloxifene	pre-dose to 96 hours
Primary	Peak Plasma Concentration (Cmax)	Cmax of corrected Cholecalciferol	pre-dose to 72 hours
Primary	Area under the curve in time plot (AUCt)	AUCt of Raloxifene	pre-dose to 96 hours
Primary	Area under the curve in time plot (AUCt)	AUCt of corrected Cholecalciferol	pre-dose to 72 hours
Secondary	Area under the curve in time plot (AUCinf)	AUCinf of Raloxifene	pre-dose to 96 hours
Secondary	Area under the curve in time plot (AUCinf)	AUCinf of Corrected Cholecalciferol	pre-dose to 72 hours
Secondary	Time to reach Cmax	Tmax of Raloxifene	pre-dose to 96 hours
Secondary	Time to reach Cmax	Tmax of Corrected Cholecalciferol	pre-dose to 72 hours
Secondary	Effective half-life	t1/2 of Raloxifene	pre-dose to 96 hours
Secondary	Effective half-life	t1/2 of Corrected Cholecalciferol	pre-dose to 72 hours