Status:
COMPLETED
Tolerability and Safety of Duloxetine BID in Healthy Female Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
FEMALE
40+ years
Phase:
PHASE1
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02232542
Start Date
June 1 2003
Last Update
September 5 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.