Trials / Completed
CompletedNCT05128591
A Study to Compare Pharmacokinetic Parameters and Safety Profiles Between AD-109 and AD-1091
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study Under Fed State to Evaluate the Safety and Pharmacokinetics of AD-109 in Healthy Male Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Addpharma Inc. · Industry
- Sex
- Male
- Age
- 19 Years
- Healthy volunteers
- Accepted
Summary
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-109 in healthy male subjects.
Detailed description
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-109 compared with AD-1091 in healthy male subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rivaroxaban 18mg Oral Tablet | AD-109 (Rivaroxaban 18mg) Oral Tablet |
| DRUG | Rivaroxaban 20 MG Oral Tablet | AD-1091 (Rivaroxaban 20mg) Oral Tablet |
Timeline
- Start date
- 2021-11-09
- Primary completion
- 2021-12-31
- Completion
- 2021-12-31
- First posted
- 2021-11-22
- Last updated
- 2022-03-08
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05128591. Inclusion in this directory is not an endorsement.