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NCT00601211 · ClinicalTrials.gov registry record · NA
Bioequivalency Study of 5 mg Piolocarpine Tablets Under Fed Conditions
A NA study of Dry Mouth, sponsored by Roxane Laboratories.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT00601211: Completed NA study of Dry Mouth, sponsored by Roxane Laboratories.
NCT00601211 is a NA study of Dry Mouth that has completed, run by Roxane Laboratories. The registered enrollment target is 28 participants, below the 365-participant average among 3 other Dry Mouth trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00601211, a NA study of Dry Mouth, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine Tablets, 5 mg, to SALAGEN® Tablets, 5 mg (MGI Pharma) under fed conditions using a single-dose, 2-treatment, 2-period, crossover design.
Conditions Studied
Interventions
- DRUG Pilocarpine
Study Locations (1)
Texas
- CEDRA Clinical Research, LLC - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2003-09 |
| Est. Completion | 2003-09 |
| Phase | NA |
What the finished NCT00601211 record still lists
NCT00601211 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 365-participant average among 3 other Dry Mouth trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Dry Mouth appearing as the primary indexed condition, and to 1 intervention - of which Pilocarpine is the first listed.
NCT00601211 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00601211 about?
NCT00601211 is a clinical study titled "Bioequivalency Study of 5 mg Piolocarpine Tablets Under Fed Conditions". The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine Tablets, 5 mg, to SALAGEN® Tablets, 5 mg (MGI Pharma) under fed conditions using a single-dose, 2-treatment, 2-period, crossover design.
What is the current status of trial NCT00601211?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2003-09. Estimated completion is 2003-09.
What conditions does trial NCT00601211 study?
This clinical trial studies the following conditions: Dry Mouth.
What interventions are being tested in trial NCT00601211?
The interventions under investigation include: Pilocarpine (DRUG).
Who is sponsoring clinical trial NCT00601211?
This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00601211 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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