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

NCT04723238 | Completed Phase 1

• 1 other identifier: HP8825-02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (4)

• Total Duloxetine: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72) ]

  17 samples up to 72 hours will be taken after the administration in each period.

  [Time Frame: From tablet intake and up to 72 hours after tablet intake]

• Total Duloxetine: area under the plasma concentration-time curve from 0 to time t (AUC0-t)

  17 samples up to 72 hours will be taken after the administration in each period.

  [Time Frame: From tablet intake and up to 72 hours after tablet intake]

• Total Duloxetine: Maximum plasma concentration (Cmax)

  17 samples up to 72 hours will be taken after the administration in each period.

  [Time Frame: From tablet intake and up to 72 hours after tablet intake]

• Total Duloxetine: Time to achieve maximum plasma concentration (tmax)

  17 samples up to 72 hours will be taken after the administration in each period.

  [Time Frame: From tablet intake and up to 72 hours after tablet intake]

Study Arms (2)

Duloxetine Test Product

EXPERIMENTAL

Participants will receive one capsule of the test formulation containing Duloxetine 60 mg. The capsules will be taken with water and in a fasting condition.

Drug: Duloxetine 60mg Test Drug Enteric Coated Granules

Duloxetine Referent Product

ACTIVE COMPARATOR

Participants will receive one capsule of the marketed reference formulation containing Duloxetine 60 mg. The capsules will be taken with water and in a fasting condition.

Drug: Duloxetine 60mg Reference Product Enteric Coated Granules

Interventions

Duloxetine 60mg Test Drug Enteric Coated Granules DRUG

Investigational Medicinal Product

Duloxetine Test Product

Duloxetine 60mg Reference Product Enteric Coated Granules DRUG

Cymbalta (Eli Lilly)

Duloxetine Referent Product

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and non-breastfeeding women
• Women of childbearing age with an acceptable form of contraception during the study
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratorios Andromaco S.A.: lead

Study Sites (1)

Innolab

Santiago, 7510491, Chile

Location

MeSH Terms

Interventions

Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 25, 2021
• Study Start: January 23, 2021
• Primary Completion: February 9, 2021
• Study Completion: March 26, 2021
• Last Updated: April 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)