Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions

Not Applicable

Completed

• Conditions: Secondary Hyperparathyroidism; Hypocalcemia

• Registration Number: NCT00601328
• Lead Sponsor: Roxane Laboratories

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Study First Submitted: 2008-01-15
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-01-28
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria

• Positive test for HIV, Hepatitis B, or Hepatitis C.
• Treatment with known enzyme altering drugs.
• History of allergic or adverse response to Calcitriol or any comparable or similar product.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Bioequivalence	Baseline, Two period, Fourteen day washout

Trial Locations

Locations (1)

Bio-Kinetic Clinical Applications, Inc.; 🇺🇸 Springfield, Missouri, United States