Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg Enteric-coated Peppermint Oil Capsule (Tempocol®), a Pharmacokinetic Study

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot study to compare the relative bioavailability between two peppermint oil formulations, namely a colon-targeted-delivery capsule (Tempocol-ColoPulse®) and an enteric-coated capsule (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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Maastricht University Medical Center
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Peppermint oil

Criteria

Inclusion Criteria:

• Based on medical history and previous examination, no gastrointestinal complaints can be defined

• Age between 18 and 65 years

• BMI between 18 and 25 kg/m2 and a weight of at least 50 kilograms

• Women in fertile age (<55 years old) must use contraception or be postmenopausal for at least two years

Exclusion Criteria:

• History of severe or chronic cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol

• Use of medication, including vitamin and iron supplementation, except oral contraceptives, within 14 days prior to start of the study

• Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study

• Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgment of the principle investigator)

• Dieting (for example lactose-free, gluten-free, caloric-restrictive, vegetarian or vegan, macrobiotic diet)

• Pregnancy, lactation

• High alcohol consumption (>15 alcoholic consumptions per week)

• Smoking/ Using drugs of abuse

• Self-admitted HIV-positive state

• Known allergic reaction to peppermint

• High intake of caffeine (>8 cups coffee a day)