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Pharmacokinetics and Safety Study of CTAP101 Capsules in Japanese and Non-Japanese Healthy Subjects and Non-Japanese Healthy Subjects

NCT03660800 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2019-09-30

No results posted yet for this study

Summary

Pharmacokinetics and Safety Study of CTAP101 Capsules in Japanese and non-Japanese Healthy Subjects

Conditions

  • Vitamin D Insufficiency
  • Secondary Hyperparathyroidism

Interventions

DRUG

CTAP101 Capsules

Calcifediol Extended-Release Capsules

Sponsors & Collaborators

  • OPKO Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeremy Mussallem · WCCT Global, Inc

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-20
Primary Completion
2018-10-24
Completion
2019-01-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03660800 on ClinicalTrials.gov