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NCT00601328 · ClinicalTrials.gov registry record · NA
Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions
A NA study, sponsored by Roxane Laboratories.
- Completed
- Registry status
- NA
- Development phase
- 36
- Enrollment target
NCT00601328: Completed NA study, sponsored by Roxane Laboratories.
NCT00601328 is a NA study that has completed, run by Roxane Laboratories. The registered enrollment target is 36 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00601328, a NA study, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
Study Summary
The objective of this study was to assess the bioequivalence of Roxane Laboratories' Calcitriol capsules, 0.25 mcg, to ROCALTROL® capsules, 0.25 mcg (Roche) using a single-dose, 2-treatment, 2-period, crossover design, under fasting conditions
Interventions
- DRUG Calcitriol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2003-07 |
| Est. Completion | 2003-08 |
| Phase | NA |
What the finished NCT00601328 record still lists
NCT00601328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Calcitriol is the first listed.
NCT00601328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00601328 about?
NCT00601328 is a clinical study titled "Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions". The objective of this study was to assess the bioequivalence of Roxane Laboratories' Calcitriol capsules, 0.25 mcg, to ROCALTROL® capsules, 0.25 mcg (Roche) using a single-dose, 2-treatment, 2-period, crossover design, under fasting conditions
What is the current status of trial NCT00601328?
This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2003-07. Estimated completion is 2003-08.
What interventions are being tested in trial NCT00601328?
The interventions under investigation include: Calcitriol (DRUG).
Who is sponsoring clinical trial NCT00601328?
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 NCT00601328's enrollment target sits among peer trials
36 1541st of 2000 higher than 437 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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