Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Fasting Conditions

• Status: Completed
• Trial end date: 2021-03-26
• Target enrollment: 0
• Participant gender: All

Summary

This Study will investigate the bioavailability in fasting subjects of 1 capsule formulation containing Duloxetine 60 mg. The Study will be performed at a single site with 36 subjects. Participants will take 1 capsule of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 14 days between each study period.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laboratorios Andromaco S.A.
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• Men and non-breastfeeding women

• Women of childbearing age with an acceptable form of contraception during the study

• 18 to 55 years old inclusive; BMI greater than or equal to 18.51 and less than or equal to 29.99

• With results of laboratory tests, electrocardiogram and chest radiography in normal and / or negative or abnormal ranges but without clinical relevance and declared suitable for study by the doctor after the physical examination

• Capable to understand the Informed Consent Form

Exclusion Criteria:

• Study site staff or family members

• With history of drug and/or alcohol abuse

• Smokers more tan 3 cigarettes every 7 days

• Vitamin supplements intake 7 days prior to the administration of the medications under study

• Any recent change in eating habits or physical exercise

• Using of a pharmacological therapy (except over the counter medication use 7 days prior to the study)

• Hypersensitivity to the study drug or to other chemically related compounds, history of serious adverse reactions or hypersensitivity to any medication

• Use, during the 28 days prior to the start of the study, of medications known to alter liver enzyme activity

• Consumption of beverages or food containing grapefruit or pink grapefruit, within 7 days prior to each administration of the study medication and consumption of alcohol, caffeine or beverages or foods containing xanthines 24 hours before each administration of the study medication until the last sample of each period

• History of any significant cardiovascular disease

• Acute disease that generates significant physiological changes from the time of selection until the end of the study

• HIV, Hepatitis B and/or C positive

• Donation or loss of a significant volume (more than 100 mL) of blood or plasma or platelets during the 3 months prior to the start of the study

• Subjects who have participated in any type of clinical study during the 3 months prior to the start of the study

• History of any gastrointestinal surgery that could affect drug absorption

• Presence of fainting history or fear to blood collection