NCT03765801

A Clinical Study in Healthy Women Which Aims to Explore the Intestinal Uptake of Two Different Tablets of GRTA9906 Into the Body and the Effect of Food on it

Phase I, Single-center Study to Explore the Relative Bioavailability and the Effect of Food on the Bioavailability of Prolonged Release Tablets Compared to Immediate Release Capsules Each Containing 60 mg of GRTA9906 in 20 Healthy Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The aim of this clinical study in healthy women is to explore the intestinal uptake (bioavailability) of two different tablets of GRTA9906 (formulations) into the body and the effect of food on it. The intake of food may considerably influence the bioavailability, either by interaction with the compound itself or, if a prolonged release (PR) formulation is used, with the components of the tablet-matrix. For these reasons, the relative bioavailability and the effect of food on the bioavailability of GRTA9906 given as PR tablets compared to immediate release (IR) capsules will be assessed in this study. During the 4 periods of the study, each participant will receive two 60 mg GRTA9906 PR matrix tablets and two 60 mg GRTA9906 IR capsules under fed conditions (after consumption of a high-fat and high-calorie test meal) and fasting conditions (10 hours before dosing until 4.5 hours after dosing). In each period, the participant will receive the investigational product once.

Conditions

• Pain
• Neuropathic Pain
• Chronic Pain
• Visceral Pain

Interventions

Type	Name	Description
DRUG	GRTA9906 60 mg PR tablet	GRTA9906 60 mg PR tablet
DRUG	GRTA9906 60 mg IR capsule	GRTA9906 60 mg IR capsule

Timeline

• Start date: 2003-10-22
• Primary completion: 2003-12-11
• Completion: 2003-12-11
• First posted: 2018-12-05
• Last updated: 2018-12-05

Locations

1 site across 1 country: Germany