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NCT00618202 · ClinicalTrials.gov registry record · NA
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions
A NA study, sponsored by Roxane Laboratories.
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
NCT00618202 is a NA study that has completed, run by Roxane Laboratories. The registered enrollment target is 52 participants.
The verdict
NCT00618202, a NA study, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
Study Summary
The objective of this study was to assess the bioequivalence of a potential generic 750 mg balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg balsalazide disodium capsule, Colazal, following a single 750 mg dose, administered under fasting conditions.
Interventions
- DRUG Balsalazide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2005-05 |
| Est. Completion | 2005-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00618202
The ClinicalTrials.gov registry entry for NCT00618202 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roxane Laboratories, which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Balsalazide is the first listed.
NCT00618202 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00618202 about?
NCT00618202 is a clinical study titled "A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions". The objective of this study was to assess the bioequivalence of a potential generic 750 mg balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg balsalazide disodium capsule, Colazal, following a single 750 mg dose, administered under fasting conditions.
What is the current status of trial NCT00618202?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2005-05. Estimated completion is 2005-06.
What interventions are being tested in trial NCT00618202?
The interventions under investigation include: Balsalazide (DRUG).
Who is sponsoring clinical trial NCT00618202?
This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.
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