Tolerability and Safety of Duloxetine BID in Healthy Female Subjects

NCT ID: NCT02232542

Last Updated: 2014-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Duloxetine - low dose

Group Type: EXPERIMENTAL

Duloxetine - low dose

Intervention Type: DRUG

Duloxetine - high dose

Group Type: EXPERIMENTAL

Duloxetine - high dose

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Duloxetine - low dose

Intervention Type: DRUG

Duloxetine - high dose

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1208.1

Identifier Type: -

Identifier Source: org_study_id