Pain Clinical Trial
Official title:
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
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.
n/a
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