HealthyNCT00778024
Bioequivalence Study of Fluoxetine HCL 40 mg Capsules Under Fasting Conditions
A study testing fluoxetine HCL 40 mg capsules in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
Trial summary
The objective of this study is to compare the relative bioavailability of fluoxetine HCL 40 mg capsules (by Ranbaxy Laboratories Limited) with that of PROZAC® 40 mg capsules (by Dista Products Company) following a single oral dose (1 x 40 mg capsule) in healthy, adult subjects under fasting conditions Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- fluoxetine HCL 40 mg capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Dec 2003
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sex: Male and Female; similar proportion of each preferred.
- Age: At least 18 years.
- Qualifying subjects must be in good health and physical condition as determined by medical history, complete physical examination, and laboratory tests, all obtained within four (4) weeks prior to study start. The subject may not have a history of significant past illness expected to affect the investigation. The normal status of subjects will be confirmed by the following procedures:
- Laboratory Tests: Hemoglobin, hematocrit, RBC, WBC, differential count, serum electrolytes (Na, K, CL), fasting blood glucose, BUN, bilirubin, creatinine, AST, ALT, LD, alkaline phosphatase, and urinalysis. HIV, Hepatitis B, Hepatitis C, and drugs of abuse testing will be done for screening purposes only. Urine drugs of abuse testing will be repeated at each check-in. Female subjects will have a serum pregnancy test done at screening and urine pregnancy test prior to each study period at check-in. Laboratory values which are greater than :E20% of the normal range will not qualify unless specifically accepted (with comment) by the Principal Investigator. Results of HIV, Hepatitis B, Hepatitis C, and drugs of abuse must be negative or non-reactive for the subject to qualify for the study.
- Electrocardiogram: A 12-lead electrocardiogram (ECG) will be obtained for all subjects. The original tracings, plus interpretation, will be included in the case report form packet.
- Subjects must read and sign the Consent Form.
Who cannot join
- Subjects not complying with the above inclusion criteria must be excluded from the study.
- In addition, any one of the conditions listed below will exclude a subject from the study:
- History of treatment for alcoholism, substance abuse, or drug abuse within past 24 months.
- History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
- History of GERD (gastroesophageal reflux disease), malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease.
- History of treatment for astlzurta within the past five (5) years.
Show all 18Show fewer
- History of neurological impairment.
- History of seizures.
- History of Parkinson's Disease.
- History of diabetes mellitus.
- Females who are pregnant or lactating.
- History of hypersensitivity to fluoxetine HCL, or any serotonin reuptake inhibitor.
- Conditions upon screening which might contraindicate or require that caution be used in the administration of fluoxetlne HCL, including:
- Sitting systolic blood pressure below 90 mm Hg, or diastolic Pressure below 50 mm Hg.
- Heart rate less than 50 beats per minute after a 5-minute rest
- Inability to read and/or sign the consent form.
- Treatment with any other investigational drug during the four (4) weeks prior to the initial dosing for this study.
- Subjects who have donated blood within four (4) weeks prior to the Initial dosing for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gateway medical research
Saint Charles, Missouri, 63301
About this study
Official title: The Objective of This Randomized, Single-dose, Two-way Evaluation is to Compare the Bioequivalence of a Test Fluoxetine HCL Formulation (Ranbaxy Laboratories Limited, Lot No. 6320101) to an Equivalent Oral Dose of the Commercially Available Fluoxetine HCL (Prozac®, Dista Products Company, Lot No 6RK57M) in a Test Population of 36 Adult Subjects Under Fasting Conditions.
The objective of this study is to compare the relative bioavailability of fluoxetine HCL 40 mg capsules (by Ranbaxy Laboratories Limited) with that of PROZAC® 40 mg capsules (by Dista Products Company) following a single oral dose (1 x 40 mg capsule) in healthy, adult subjects under fasting conditions
Read the detailed description
This is a single-dose, open-label, randomized two-way crossover study to evaluate the bioequivalence of a test formulation, versus an equivalent dose of a commercially available reference drug product, in 36 adult subjects, under fasted conditions. Drug administrations are separated by at least 49 days.
Vital signs (sitting blood pressure and pulse rate) were obtained at baseline (Hour 0), and at post-dose Hours 3, 8, 12, 24, 48, 72, 360, and 1056.
Of the 36 subjects enrolled into the study, 31 subjects completed the study in its entirety. Five (5) subjects were dropped out from the study.
- Conditions
- Healthy
- Being tested
- fluoxetine HCL 40 mg capsules
- Keywords
- Bioequivalence fluoxetine HCL 40 mg capsules fasting conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluoxetine HCL 40 mg capsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | fluoxetine HCL 40 mg capsules of ranbaxy Receives: Drug: fluoxetine HCL 40 mg capsules |
| 2 | Active comparator | PROZAC® 40 mg capsules Receives: Drug: fluoxetine HCL 40 mg capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startAug 2003
- Primary completionOct 2003
- Study completionDec 2003
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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778024
- Sponsor's protocol ID
- 03197
- Status last verified
- Dec 2009
- First submitted
- 22 Oct 2008
- Last updated
- 15 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Objective of This Randomized, Single-dose, Two-way Evaluation is to Compare the Bioequivalence of a Test Fluoxetine HCL Formulation (Ranbaxy Laboratories Limited, Lot No. 6320101) to an Equivalent Oral Dose of the Commercially Available Fluoxetine HCL (Prozac®, Dista Products Company, Lot No 6RK57M) in a Test Population of 36 Adult Subjects Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT00778024
- Acronym / sponsor ID
- 03197
- Conditions
- Healthy
- Keywords
- Bioequivalence fluoxetine HCL 40 mg capsules fasting conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Oct 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 23 Oct 2008 (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.
The objective of this study is to compare the relative bioavailability of fluoxetine HCL 40 mg capsules (by Ranbaxy Laboratories Limited) with that of PROZAC® 40 mg capsules (by Dista Products Company) following a single oral dose (1 x 40 mg capsule) in healthy, adult subjects under fasting conditions
Detailed description
This is a single-dose, open-label, randomized two-way crossover study to evaluate the bioequivalence of a test formulation, versus an equivalent dose of a commercially available reference drug product, in 36 adult subjects, under fasted conditions. Drug administrations are separated by at least 49 days.
Vital signs (sitting blood pressure and pulse rate) were obtained at baseline (Hour 0), and at post-dose Hours 3, 8, 12, 24, 48, 72, 360, and 1056.
Of the 36 subjects enrolled into the study, 31 subjects completed the study in its entirety. Five (5) subjects were dropped out from the study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: fluoxetine HCL 40 mg capsulesfluoxetine HCL 40 mg capsules of ranbaxy |
| 2 | Active comparator | Drug: fluoxetine HCL 40 mg capsulesPROZAC® 40 mg capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sex: Male and Female; similar proportion of each preferred.
- Age: At least 18 years.
- Qualifying subjects must be in good health and physical condition as determined by medical history, complete physical examination, and laboratory tests, all obtained within four (4) weeks prior to study start. The subject may not have a history of significant past illness expected to affect the investigation. The normal status of subjects will be confirmed by the following procedures:
- Subjects must read and sign the Consent Form.
Key exclusion criteria (18 listed)
- Subjects not complying with the above inclusion criteria must be excluded from the study.
- In addition, any one of the conditions listed below will exclude a subject from the study:
- Conditions upon screening which might contraindicate or require that caution be used in the administration of fluoxetlne HCL, including:
- Inability to read and/or sign the consent form.
- Treatment with any other investigational drug during the four (4) weeks prior to the initial dosing for this study.
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 |
|---|---|---|
| fluoxetine HCL 40 mg capsules | Drug | 1, 2 |
Primary outcome
Bioequivalence
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 15 Dec 2009.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluoxetine HCL 40 mg capsules in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
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 6 inclusion and 18 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 15 Dec 2009. 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 United States. 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.
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?
Bioequivalence. 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 15 Dec 2009.