Trials / Completed
CompletedNCT03627936
A Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen in Healthy Participants
A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen Under Fasted Conditions in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to demonstrate the bioequivalence between lorcaserin XR tablets manufactured in Kawashima and lorcaserin XR tablets manufactured in Zofingen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lorcaserin manufactured at Zofingen | Lorcaserin XR tablets manufactured at Zofingen. |
| DRUG | Lorcaserin manufactured at Kawashima | Lorcaserin XR tablets manufactured at Kawashima. |
Timeline
- Start date
- 2018-08-07
- Primary completion
- 2018-09-02
- Completion
- 2018-09-02
- First posted
- 2018-08-14
- Last updated
- 2018-10-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03627936. Inclusion in this directory is not an endorsement.