Table 3 Exclusion criteria at study periods

33

For female subjects of child bearing potential: positive or missing pregnancy test

To protect a fetus

34

Positive or missing urine test for drugs of abuse (opioids, amphetamines, benzodiazepines, cannabinoids).

Subject safety and to avoid interactions with, e.g., tapentadol (PD interactions, safety interactions)

35

Blood loss of 500 mL or more (e.g., owing to blood donation) since screening.

To ascertain the subject’s suitability for the study

36

Any other reason to exclude the subject according to judgment by the investigator

To avoid interference with the purpose of the study.

37

Alcohol consumption in the last 48 h prior to the study period.

Subject safety and to avoid interactions with, e.g., tapentadol (PD interactions, safety interactions)

38

Intake of any drug including herbal medicines and other remedies except the following: contraceptives; oral paracetamol or ibuprofen up to the maximum recommended dose according SmPC, with last intake for both > 4 days prior to each study period for a self-resolving condition.

As described for screening visit

39

Changes in physical exercise activities, e.g., starting workout/training within 1 week prior to the study.

To avoid interference with the purpose of the study

40

Current pain within the last 4 days before the study period.

To avoid interference with the purpose of the study

41

Any transient, clinically relevant illness within 4 days before the period.

To ensure the subject’s good health

42

Incidentally not willing or able to comply with the requirements of the trial protocol or the instructions or to communicate meaningfully with the trial site staff.

To ascertain the subject’s suitability for the study

43

Incidentally unable to take oral medication.

Requirement for the study

44

Jet lag / irregular working hours / sleep restriction in the last 3 days before the period.

To avoid interference with the purpose of the study