Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions

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

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Key information

Conditions

Secondary Hyperparathyroidism Calcium Metabolism Disorders Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Hypocalcemia Metabolic Diseases Nutritional and Metabolic Diseases Parathyroid Diseases Water-Electrolyte Imbalance

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bio-Kinetic Clinical Applications, Inc.

Springfield, Missouri, 65801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

calcitriol

Drug

Primary outcomes

Bioequivalence

Time frame: Baseline, Two period, Fourteen day washout

Sponsors and collaborators

Lead sponsor

Roxane Laboratories

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2003
Study completion: 2003
First posted: Jan 28, 2008
Registry last updated: Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed