Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions - Full Text View

Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions

This study has been completed.

Sponsored by:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00601328

Purpose

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

Condition	Intervention
Secondary Hyperparathyroidism Hypocalcemia	Drug: Calcitriol

Drug Information available for:

Calcitriol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

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

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

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

Enrollment:	36
Study Start Date:	July 2003
Study Completion Date:	August 2003
Primary Completion Date:	August 2003 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601328

Locations


United States, Missouri
	Bio-Kinetic Clinical Applications, Inc.
	Springfield, Missouri, United States, 65801

Sponsors and Collaborators

Roxane Laboratories

Investigators


Principal Investigator:	Dennis Morrison, DO	Bio-Kinetic Clinical Applications, Inc.

More Information

Responsible Party:	Roxane Laboratories, Inc. ( Elizabeth A. Ernst, Director, Drug Regulatory Affairs and Medical Affairs )
Study ID Numbers:	CALC-07
First Received:	January 15, 2008
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00601328
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Parathyroid Diseases

Hyperparathyroidism, Secondary

Hypocalcemia

Metabolic Diseases

Hyperparathyroidism

Neoplasm Metastasis

Endocrine System Diseases

Water-Electrolyte Imbalance

Endocrinopathy

Metabolic disorder

Calcitriol

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Growth Substances

Physiological Effects of Drugs

Calcium Channel Agonists

Bone Density Conservation Agents

Cardiovascular Agents

Pharmacologic Actions

Calcium Metabolism Disorders

Membrane Transport Modulators

Vitamins

Therapeutic Uses

Vasoconstrictor Agents

Micronutrients

ClinicalTrials.gov processed this record on October 28, 2008