Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions

Secondary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00601328
• Other study ID #: CALC-07
• Status: Completed
• Phase: N/A
• First received: January 15, 2008
• Last updated: January 19, 2018
• Start date: July 2003
• Est. completion date: August 2003

Study information

• Verified date: January 2018
• Source: West-Ward Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Hypocalcemia
• Secondary Hyperparathyroidism

Intervention

Drug:
• Calcitriol

Locations

Country	Name	City	State
United States	Bio-Kinetic Clinical Applications, Inc.	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence		Baseline, Two period, Fourteen day washout