Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (bp), pulse rate (pr)), 12-lead electrocardiogram (ecg), and clinical laboratory tests age of 18 to 50 years (inclusive) at screening body mass index (bmi) of 18.5 to 29.9 kg/m2 (inclusive) at screening signed and dated written informed consent prior to admission to the study, in accordance with good clinical practice (gcp) and local legislation male subjects who meet any of the following criteria from first administration of trial medication until 30 days after trial completion: use of adequate contraception by the female partners, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea sexually abstinent vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (e.g. condom) sperm donation is not allowed from first study drug administration until 30 days after trial completion.

inclusion criteria: healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (bp), pulse rate (pr)), 12-lead electrocardiogram (ecg), and clinical laboratory tests age of 18 to 50 years (inclusive) at screening body mass index (bmi) of 18.5 to 29.9 kg/m2 (inclusive) at screening signed and dated written informed consent prior to admission to the study, in accordance with good clinical practice (gcp) and local legislation male subjects who meet any of the following criteria from first administration of trial medication until 30 days after trial completion: use of adequate contraception by the female partners, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea sexually abstinent vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (e.g. condom) sperm donation is not allowed from first study drug administration until 30 days after trial completion.