Trial | NCT00601328  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    calcitriol ...

  • Study Participants

    36
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 Started
Jul 31
2003
Primary Completion
Aug 31
2003
Study Completion
Aug 31
2003
Last Update
Jan 23
2018

Drug Calcitriol

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.
No Results Posted