Bioequivalence Study of Paricalcitol Capsules, 4 mcg Under Fasting Conditions
NCT02322632 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69
Last updated 2014-12-23
Summary
An open-label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover oral bioequivalence study in healthy subjects under fasting conditions.
Conditions
- Healthy
Interventions
- DRUG
-
Paricalcitol Capsules, 4 mcg
Paricalcitol Capsules, 4 mcg of Dr. Reddy's Laboratories Limited
Sponsors & Collaborators
-
Dr. Reddy's Laboratories Limited
lead INDUSTRY
Principal Investigators
-
Dr. Pankaj Kumar Jha, MD · Lambda Therapeutic Research Limited
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-11-30
- Primary Completion
- 2010-12-31
- Completion
- 2011-02-28
Countries
- India
Study Locations
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