NCT03641248

Bioavailability and Pharmacokinetic Measures of H. Procumbens Extract

Study to Establish the Bioavailability and Pharmacokinetic Measures of H. Procumbens Extract in Humans

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study will define the bioavailability and short term pharmacokinetics of the principal secondary metabolites of a aqueous-ethanolic extract of H. procumbens in non-enteric and enteric capsules.

Detailed description

The study(n = 12) will use a one-dose design to measure bioavailability and pharmacokinetic properties of an aqueous extract of H. procumbens containing 100mg harpagoside. Plasma levels of harpagoside, harpagide, verbascoside, and 8-p-coumarylharpagide will be measured for 24 hours with blood collections taken at timed intervals.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Enteric coated Devil's Claw	Enteric coated capsules containing Devil's Claw extract with 100mg harpagoside
DRUG	Non-enteric coated Devil's Claw	Non-enteric coated capsules containing Devil's Claw extract with 100mg harpagoside

Timeline

• Start date: 2021-05-01
• Primary completion: 2021-07-31
• Completion: 2021-08-31
• First posted: 2018-08-21
• Last updated: 2022-05-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study