Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions

Roxane Laboratories36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Secondary Hyperparathyroidism Hypocalcemia

Interventions

CalcitriolDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Bio-Kinetic Clinical Applications, Inc.

Springfield, Missouri, United States

Outcomes

Primary Outcomes

Bioequivalence

Time frame: Baseline, Two period, Fourteen day washout

Data from ClinicalTrials.gov

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