Tolerability and Safety of Duloxetine BID in Healthy Female Subjects

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: Duloxetine - low dose

Drug: Duloxetine - high dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT02232542

1208.1

Details and patient eligibility

About

Study to assess the safety and tolerability of 100 mg of duloxetine BID compared to 40 mg of duloxetine BID or placebo for 7 days

Enrollment

32 patients

Sex

Female

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy female subjects as determined by results of screening
Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
Age ≥ 40 years
BMI ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion criteria

Any finding at any of the medical examinations (including blood pressure, pulse rate and ECG (electrocardiogram)) deviating from normal and of clinical relevance (resting heart rate greater than 100 bpm or tachyarrhythmia)
History of or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders (except thyroid hormones and hormonal replacement therapy)
History of relevant orthostatic hypotension, fainting spells and blackouts
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
Chronic or relevant acute infections
History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator, any bleeding disorder including prolonged or habitual bleeding, other hematologic disease, cerebral bleeding (e.g. after a car accident), commotio cerebri
Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
Use of any drugs that might influence the results of the trial (especially CYP2D6 or CYP1A2 modulating substances) within 2 weeks prior to administration or during the trial
Participation in another trial with an investigational drug within 2 months prior to administration or during trial
Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
Alcohol abuse (> 60 g/day)
Caffeine abuse (> 4 cups/day)
Drug abuse
Blood donation within 1 month prior to administration or during the trial
Excessive physical activities within 10 days prior to administration or during the trial
Any laboratory value outside the clinically accepted reference range
Ineffective contraception