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NCT03357796 · ClinicalTrials.gov registry record · Phase 1
Relative Bioavailability (RBA) Study of LY03005 vs Pristiq®
A Phase 1 study, sponsored by Luye Pharma Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT03357796: Completed Phase 1 study, sponsored by Luye Pharma Group.
NCT03357796 is a Phase 1 study that has completed, run by Luye Pharma Group. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03357796, a Phase 1 study, has completed, sponsored by Luye Pharma Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate relative bioavailability between 80 mg LY03005 oral tablets and 50 mg Pristiq® oral tablets after a single dose of each drug in a cross-over 2-period design under fasting condition in healthy subjects between 18 and 50 years of age.
Primary Outcome
Area under the concentration-time curve (AUC) for the Pharmacokinetics (PK) of O-desmethyl-venlafaxine (ODV) from LY03005 and ODV from Pristiq will be determined.
Interventions
- DRUG LY03005
- DRUG Pristiq
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-11-27 |
| Est. Completion | 2017-12-22 |
| Phase | Phase 1 |
What the finished NCT03357796 record still lists
NCT03357796 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which LY03005 is the first listed.
NCT03357796 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03357796 about?
NCT03357796 is a clinical study titled "Relative Bioavailability (RBA) Study of LY03005 vs Pristiq®". The objective of this study is to evaluate relative bioavailability between 80 mg LY03005 oral tablets and 50 mg Pristiq® oral tablets after a single dose of each drug in a cross-over 2-period design under fasting condition in healthy subjects between 18 and 50 years of age.
What is the current status of trial NCT03357796?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2017-11-27. Estimated completion is 2017-12-22.
What interventions are being tested in trial NCT03357796?
The interventions under investigation include: LY03005 (DRUG), Pristiq (DRUG).
Who is sponsoring clinical trial NCT03357796?
This trial is sponsored by Luye Pharma Group, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03357796's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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