HealthyPhase 1NCT02291367
Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg Under Fasting 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.
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 fasting 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
- Be healthy human between 18 and 45 years
- Screened within 21 days prior to administration of first dose of study drug
- Having a BMI between 18.5 and 24.9 weight in kg/ height2 in meter
- Be able to communicate effectively with study personnel
- Be able to give Written informed consent to participate in the study If subject is a female volunteer and
- 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
- History of allergic responses to Duloxetine or other related drugs.
- Have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG \& X-ray recordings.
- Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
- History or presence of bronchial asthma.
- Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
- History of drug dependence, recent history of alcoholism or of moderate alcohol use.
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- 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 can not refrain from smoking during study period.
- History of difficulty with donating blood or difficulty in accessibility of veins. Donation of blood (I unit: 350 mL/450 mL) within 90 days prior to receiving the first dose of study medication.
- A positive hepatitis screen (includes subtypes A, B, C \& E)
- A positive test result for HIV antibody and/or syphilis (RPR/VDRL).
- The receipt of an investigational product, or participation in a drug research study within a period of 90 days prior to the frst dose of 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.
About this study
Official title: Single Dose Crossover Comparative Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg in Healthy Adult Human Subjects Under Fasting 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 fasting 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 fasting 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 group | Role | What they receive |
|---|---|---|
| Duloxetine Delayed-Release Capsules, 60 mg | Experimental | Not described Receives: Drug: Duloxetine |
| Cymbalta | Active comparator | Cymbalta® 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.
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.
- First posted14 Nov 2014 (estimated)
- Study startMay 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mayur Soni, MBBS, Principal investigator, BA Research India Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291367
- Sponsor's protocol ID
- BA085908801
- Status last verified
- Jul 2008
- First submitted
- 11 Nov 2014
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Crossover Comparative Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg in Healthy Adult Human Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT02291367
- Acronym / sponsor ID
- BA085908801
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 fasting conditions and to monitor safety of subjects
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 fasting conditions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetine Delayed-Release Capsules, 60 mg | Experimental | Drug: Duloxetine |
| Cymbalta | Active comparator | Drug: Cymbalta®Cymbalta® 60 mg capsule of Eli Lilly and Company |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Be healthy human between 18 and 45 years
- Screened within 21 days prior to administration of first dose of study drug
- Having a BMI between 18.5 and 24.9 weight in kg/ height2 in meter
- Be able to communicate effectively with study personnel
- Be able to give Written informed consent to participate in the study If subject is a female volunteer and
Key exclusion criteria (14 listed)
- History of allergic responses to Duloxetine or other related drugs.
- Have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG \& X-ray recordings.
- Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
- History or presence of bronchial asthma.
- Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuloxetineAlso: CymbaltaDuloxetine Delayed-Release Capsules 60 mg | Drug | Duloxetine Delayed-Release Capsules, 60 mg |
| Cymbalta®60 mg capsule of Eli Lilly and Company | Drug | Cymbalta |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mayur Soni, MBBS principal investigator
BA Research India Ltd
1 site in 1 country: see every site and its status.
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 8 inclusion and 14 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?
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.