NCT00601328

Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions

A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Calcitriol Tablets, 0.25 mg, Under Fasting Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Roxane Laboratories · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Secondary Hyperparathyroidism
• Hypocalcemia

Interventions

Type	Name	Description
DRUG	Calcitriol

Timeline

• Start date: 2003-07-01
• Primary completion: 2003-08-01
• Completion: 2003-08-01
• First posted: 2008-01-28
• Last updated: 2018-01-23

Locations

1 site across 1 country: United States