Evaluating the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers

Osteoporosis Clinical Trial

Official title:

A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03764462
• Other study ID #: AD-101BE
• Status: Completed
• Phase: Phase 1
• Start date: December 14, 2018
• Est. completion date: February 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-101 in healthy volunteers

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 8, 2019
• Est. primary completion date: January 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• AD-101 45mg
Raloxifene 45mg tablet
• Raloxifene 60mg
Raloxifene 60mg tablet

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Hospital	Daegu

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 40 Days
Primary	Peak Plasma Concentration (Cmax)	Cmax of the total ingredient of AD-101	pre-dose to 96 hours
Primary	Area under the curve in time plot (AUCt)	AUCt of the total ingredient of AD-101	pre-dose to 96 hours
Secondary	Area under the curve in time plot (AUCinf)	AUCinf of the total ingredient of AD-101	pre-dose to 96 hours
Secondary	Time to reach Cmax	Tmax of the total ingredient of AD-101	pre-dose to 96 hours
Secondary	Effective half-life	t1/2 of the total ingredient of AD-101	pre-dose to 96 hours
Secondary	Clearance	CL/F of the total ingredient of AD-101	pre-dose to 96 hours
Secondary	Volume of distribution	Vd/F of the total ingredient of AD-101	pre-dose to 96 hours