Status:
COMPLETED
Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Feeding Conditions
Lead Sponsor:
Laboratorios Andromaco S.A.
Conditions:
Bioequivalence
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 wil...
Detailed Description
The primary objective of the study is to investigate the relative bioavailability of Duloxetine of 1 capsule formulation with Duloxetine 60 mg under feeding conditions to demonstrate bioequivalence of...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04751318
Start Date
February 27 2021
End Date
March 16 2021
Last Update
April 15 2021
Active Locations (1)
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1
Innolab
Santiago, Chile, 7510491