Back to resultsBioequivalency Study of Calcitriol Tablets Under Fasting Conditions
Primary Purpose
Secondary Hyperparathyroidism, Hypocalcemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Calcitriol
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism
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.
Sites / Locations
- Bio-Kinetic Clinical Applications, Inc.
Outcomes
Primary Outcome Measures
Bioequivalence
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00601328
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Roxane Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism, Hypocalcemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Primary Outcome Measure Information:
Title
Bioequivalence
Time Frame
Baseline, Two period, Fourteen day washout
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Morrison, DO
Organizational Affiliation
Bio-Kinetic Clinical Applications, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bio-Kinetic Clinical Applications, Inc.
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65801
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions
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