Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01009697 · ClinicalTrials.gov registry record · Phase 1
Dose Linearity Study of Codeine Sulfate Under Fasted Conditions
A Phase 1 study, sponsored by Roxane Laboratories.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT01009697: Completed Phase 1 study, sponsored by Roxane Laboratories.
NCT01009697 is a Phase 1 study that has completed, run by Roxane Laboratories. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01009697, a Phase 1 study, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
The objective of this study was to examine the dose linearity of Roxane Laboratories' 15 mg, 30 mg, and 60 mg codeine sulfate tablets under fasted conditions
Interventions
- DRUG Codeine Sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2008-03 |
| Est. Completion | 2008-04 |
| Phase | Phase 1 |
What the finished NCT01009697 record still lists
NCT01009697 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which Codeine Sulfate is the first listed.
NCT01009697 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01009697 about?
NCT01009697 is a clinical study titled "Dose Linearity Study of Codeine Sulfate Under Fasted Conditions". The objective of this study was to examine the dose linearity of Roxane Laboratories' 15 mg, 30 mg, and 60 mg codeine sulfate tablets under fasted conditions
What is the current status of trial NCT01009697?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2008-03. Estimated completion is 2008-04.
What interventions are being tested in trial NCT01009697?
The interventions under investigation include: Codeine Sulfate (DRUG).
Who is sponsoring clinical trial NCT01009697?
This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01009697's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02897063 · 34 participants · Phase 1
Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure
- NCT03906617 · 34 participants · Phase 4
Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine
- NCT03992378 · 34 participants · NA
Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis
- NCT04047849 · 34 participants · Phase 4
Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia