Intervention: Fluoxetine
Trial phase: Not Applicable
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Only arm in the study. Successive Control (Study Days 1 and 3) and fluoxetine multiple-dose treatment (Study Days 16 and 18) Sessions.

Fluoxetine: 1x20mg oral fluoxetine capsules by mouth daily on Study Day 5, then 3x20mg fluoxetine capsules by mouth daily on Study Days 6 through 18.
Eligibility criteria:
Inclusion Criteria:

Subjects must be 18-50 years old.
Subjects must be currently in good health with normal gastrointestinal and heart function (as determined by medical history)
Laboratory values indicating normal liver (Serum Albumin 3.9 - 5.0 g/dL, Total Bilirubin < 1.4mg/dL, Alanine Transaminase 9 - 60 IU/L and Aspartate Transaminase 10 - 40 IU/L) and kidney (Serum Creatinine < 1.5 mg/dL and Blood Urea Nitrogen 7 - 20 mg/dL) function as well as normal blood glucose values (Fasting Blood Glucose < 100 mg/dL).
Subjects must have no known allergies to fluoxetine or other selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), benzodiazepine drugs, caffeine, omeprazole, dextromethorphan, lovastatin or any chemically related drug.
Women of childbearing age must be willing to use measures to avoid conception during the study period and willing to have a pregnancy test on Study Days 1 and 16.
Subjects must agree not to take any known substrates, inhibitors, inducers or activators of cytochrome P450 (CYP) CYP1A2, CYP3A4, CYP2C19 and CYP2D6 for two weeks before the start of each study through three weeks after the last day of study. This list includes but is not restricted to antidepressant and antipsychotic agents, azole antifungal agents, macrolide antibiotics, anti-epileptic medications, antihypertensive agents and cholesterol lowering agents. They must also be willing to avoid ingesting grapefruit, grapefruit juice or other grapefruit containing products, and any herbal-based nutrient supplement or medication for the same period of time. Use of oral contraceptives will be permitted.
Subjects must be willing to avoid caffeine-containing foods, beverages, or dietary supplements for 24 hrs prior to and throughout each study session and avoid alcohol for 48 hrs prior to and throughout each study session.
Subjects must be willing to avoid heavy exercise during the study

Exclusion Criteria:

Current cigarette smoker
History of liver, kidney, gastrointestinal or heart disease
Lab test results indicative of abnormal liver or kidney function, or diabetes (see above inclusion criteria).
Allergy to any monoamine oxidase inhibitors (MAOIs) or any other chemically related drug or to benzodiazepine drug
Prior experience of side effects to fluoxetine or other selective serotonin reuptake inhibitors (SSRIs)
CYP2D6 or CYP2C19 poor metabolizer genotype or CYP3A5 expressor genotype
Recent ingestion (< 2 weeks) of any medication known to be metabolized by or alter CYP1A2, CYP3A4, CYP2C19 or CYP2D6 activity
A positive pregnancy test or breastfeeding
History of diabetes, peptic ulcer or inflammatory bowel disease
Overweight; a body mass index ≥ 30 or underweight; a body mass index of ≤ 18
Use of chronic prescription or over-the-counter medications (except oral contraceptives)
Use of antidepressants during the last two weeks preceding the study