Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 15, 2008

Last Updated Date

January 31, 2008

Start Date ^†

July 2003

Current Primary Outcome Measures ^†

Bioequivalence [ Time Frame: Baseline, Two period, Fourteen day washout ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00601328 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions

Official Title ^†

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

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

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Condition ^†

Secondary Hyperparathyroidism
Hypocalcemia

Intervention ^†

Drug: Calcitriol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

August 2003

Primary Completion Date

August 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00601328

Responsible Party

Elizabeth A. Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.

Secondary IDs ^††

Study Sponsor ^†

Roxane Laboratories

Collaborators ^††

Investigators ^†

Principal Investigator:

Dennis Morrison, DO

Bio-Kinetic Clinical Applications, Inc.

Information Provided By

Roxane Laboratories

Verification Date

January 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.