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HealthyPhase 1NCT02291341

Bioavailability Study of Duloxetine Delayed-Relase Capsules 60 mg Under Fed Condition

A Phase 1 study testing Duloxetine and Cymbalta® in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study were to compare the relative bioavailability of Duloxetine HCl delayed release capsule 60 mg with that of 'CYMBALTA®' delayed release capsule 60 mg (Duloxetine HCl delayed release capsule 60 mg) in healthy, adult, human subjects under fed conditions and to monitor safety of subjects Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Duloxetine and Cymbalta®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteIndia
Study dates
May 2008to May 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The subjects should be healthy human between 18 and 45 years.
  • The subjects should be screened within 21 days prior to the administration of first dose of the study drug.
  • The subjects should have a BMI between 18.5 and 24.9 weight in kg/ height2 in meter.
  • The subjects should be able to communicate effectively with study personnel.
  • The subjects should be able to give written informed consent to participate in the study.
  • If subject is a female volunteer and
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  • Is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
  • Is postmenopausal for at least 1 year.
  • Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).

Who cannot join

  • The subjects who have a history of allergic responses to Duloxetine or other related drugs.
  • The subjects who have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG and X-ray recordings.
  • The subjects who have any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
  • The subjects who have a history or presence of bronchial asthma.
  • The subject who have used enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
  • The subjects who have history of drug dependence, recent history of alcoholism or of moderate alcohol use.
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  • The subjects who are smokers, who smoke more than or equal to 10 cigarettes per day or more than or equal to 20 biddies per day or those who cannot refrain from smoking during study period.
  • The subjects with a history of difficulty with donating blood or difficulty in accessibility of veins.
  • The subjects who have donated (1 unit: 350 ml / 450 ml) blood within 90 days prior to receiving the first dose of study medication.
  • The subjects who have a positive hepatitis screen (includes subtypes A, B, C \& E).
  • The subjects who have a positive test result for HIV antibody and / or syphilis (RPR/VDRL).
  • The subject who receives an investigational product, or has participated in a drug research study within a period of 90 days prior to the first dose of the study medication administration.
  • Female volunteers demonstrating a positive pregnancy screen.
  • Female volunteers who are currently breast-feeding.
  • Female volunteers not willing to use contraception during the study.

Trial locations and contacts

1 site in 1 country.

India1 site

  • BA Research India Ltd

    Ahmedabad, Gujarat, 380 054

Other trials in India

About this study

Official title: Single Dose Crossover Comparative Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg in Healthy Adult Human Subjects Under Fed Conditions

This study were to compare the relative bioavailability of Duloxetine HCl delayed release capsule 60 mg with that of 'CYMBALTA®' delayed release capsule 60 mg (Duloxetine HCl delayed release capsule 60 mg) in healthy, adult, human subjects under fed conditions and to monitor safety of subjects

Read the detailed description

Open label, randomized, two period, two treatment, two sequence, crossover, balanced, single dose comparative oral bioavailability study in healthy, adult, human subjects under fed conditions

Conditions
Healthy
Being tested
Duloxetine, Cymbalta®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DuloxetineDrug

    Also called Cymbalta

    Duloxetine Delayed-Release Capsules 60 mg

  • Cymbalta®Drug

    60 mg capsule of Eli Lilly and Company

Study groups in NCT02291341
Study groupRoleWhat they receive
Duloxetine Delayed-Release Capsules, 60 mgExperimentalDuloxetine Delayed-Release Capsules, 60 mg of Dr. Reddys Laboratories Limited
Receives: Drug: Duloxetine
CymbaltaActive comparatorCymbalta® 60 mg capsule of Eli Lilly and Company
Receives: Drug: Cymbalta®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under curve (AUC)

    Measured: 1.0, 2.0,3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 11.0, 12.0, 24.0, 36.0, 48.0,60.0 and 72.0 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2014 (estimated)
  2. Study startMay 2008
  3. Primary completionMay 2008
  4. Study completionMay 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02291341
Sponsor's protocol ID
BA0859089-01
Status last verified
Jul 2008
First submitted
11 Nov 2014
Last updated
14 Nov 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Duloxetine and Cymbalta® in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under curve (AUC) (time frame: 1.0, 2.0,3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 11.0, 12.0, 24.0, 36.0, 48.0,60.0 and 72.0 hours post dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02291341.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2014.

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