A Randomized, Double Blind, Single Dose, Two Treatment, Two Period Crossover Pharmacokinetic Study Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg Enteric-coated Peppermint Oil Capsule (Tempocol®) in Healthy Volunteers

NCT02291445 Phase 2 COMPLETED Results posted

This is a pilot study to compare the relative bioavailability between two peppermint oil formulations, namely a ileocolonic release peppermint oil and an small intestinal release peppermint oil (Tempocol®). This study is conducted as part of a future multicenter randomized controlled trial that will assess the therapeutic effect of the new peppermint oil formulation in IBS patients.

Details

Lead sponsor	Maastricht University Medical Center
Phase	Phase 2
Status	COMPLETED
Enrolment	8
Start date	2015-03
Completion	2015-09

Conditions

• Irritable Bowel Syndrome
• Abdominal Pain
• Colonic Diseases
• Visceral Pain

Interventions

• Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule)
• Menthae piperitae aetheroleum/peppermint oil (colon-targeted-delivery capsule)

Primary outcomes

• T-max — 24 hours
  Time to reach maximum menthol-glucuronide (main constituent of peppermint oil after conversion by the liver) concentration in plasma

Countries

Netherlands