NCT03660800

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

An Open-label, Single-Dose, Safety, Tolerability and Pharmacokinetic Study of Oral CTAP101 (Calcifediol) Extended-release Capsules in Japanese and Non-Japanese Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

An Open-label, Single-Dose, Safety, Tolerability and Pharmacokinetic Study of Oral CTAP101 (Calcifediol) Extended-release Capsules in Japanese and non-Japanese Healthy Subjects

Conditions

• Vitamin D Insufficiency
• Secondary Hyperparathyroidism

Interventions

Type	Name	Description
DRUG	CTAP101 Capsules	Calcifediol Extended-Release Capsules

Timeline

• Start date: 2018-08-20
• Primary completion: 2018-10-24
• Completion: 2019-01-22
• First posted: 2018-09-07
• Last updated: 2019-09-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study