NCT02656810

A Comparison Study of PF708 and Forteo in Healthy Subjects

A Double-Masked, Randomized, Two-Treatment Cross-over Study Comparing the Pharmacokinetics of PF708 and Forteo Administered by Subcutaneous Injection in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Pfenex, Inc · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the pharmacokinetics (blood levels) of two teriparatide products, PF708 and Forteo, in healthy subjects.

Detailed description

This is a double-masked, randomized, two-treatment cross-over study in healthy adult subjects. Half of the subjects will be randomized to receive PF708 first and Forteo second (Sequence A), and the other half will be randomized to receive the drugs in reverse sequence (Sequence B),

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Teriparatide	Single subcutaneous injection

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2016-01-15
• Last updated: 2016-08-04

Locations

1 site across 1 country: United States