Phase 2
Completed N=8
Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg Enteric-coated Peppermint Oil Capsule (Tempocol®), a Pharmacokinetic Study
Source: ClinicalTrials.gov NCT02291445 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcomePrimary: T-max — 360; 180 minutes
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY T-max |
360; 180 | — |
| SECONDARY C-max |
563.6; 702 | — |
| SECONDARY T-lag |
225; 37 | — |
| SECONDARY AUC |
2331; 2623 | — |
| SECONDARY T1/2 |
6.1; 7.7 | — |
| SECONDARY Menthol-glucuronide Urine Exretion Time Curve |
— | — |
| SECONDARY L-Menthol Concentration in Feces |
— | — |
| SECONDARY Difference in Total Number of Side Effects Per Time Point. |
— | — |
| SECONDARY Tolerability Assessed by Heart Rate, Blood Pressure and Reported Side Effects |
— | — |
Eligibility 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 ( 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)
Data sourced from ClinicalTrials.gov (NCT02291445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.