HealthyPhase 1NCT00835575

15 mg Mirtazapine Orally Disintegrating Tablets, Fasting

A Phase 1 study testing Mirtazapine 15 mg (Orally Disintegrating) Tablets and REMERON SolTab® 15 mg Orally Disintegrating Tablets in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.

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 will compare the relative bioavailability (rate and extent of absorption) of 15 mg Mirtazapine (Orally Disintegrating) Tablets manufactured by TEVA Pharmaceutical Industries, Ltd.; distributed by TEVA Pharmaceuticals USA with that of 15 mg REMERON SolTab® Orally Disintegrating Tablets manufactured for… 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?: Mirtazapine 15 mg (Orally Disintegrating) Tablets and REMERON SolTab® 15 mg Orally Disintegrating Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: Jul 2003to Aug 2003
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Screening Demographics: All subjects selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The subject's body mass index (BMI) should be less than or equal to 30.
Screening Procedures: Each subject will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before fill implementation of screening procedures.
Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
The screening clinical laboratory will include:
Hematology: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count;
Clinical Chemistry: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase;

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HIV antibody, hepatitis B surface antigen, and hepatitis C antibody screens;
Urinalysis: by dipstick; full microscopic examination of dipstick positive; and
Urine Drug Screen: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine.
Serum Pregnancy Screen (female subjects only)
If female and:
of childbearing potential, is practicing an acceptable barrier method of birth control for the duration of the study as judged by the investigator(s), such as condoms, sponge, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or
is postmenopausal for at least 1 year; or
is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

Who cannot join

Subjects with a recent history of drug or alcohol addiction or abuse.
Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
Subjects demonstrating a positive hepatitis B surface antigen screen, hepatitis C antibody screen, or a reactive HIV antibody screen.
Subjects demonstrating a positive pregnancy screen.
Subjects who are currently breastfeeding.

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Subjects with a history of clinically significant allergies including drug allergies.
Subjects with a history of allergic response(s) to mirtazapine or related drugs.
Subjects with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
Subjects who currently use of have used tobacco products within 90 days of Period I dosing.
Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
Subjects who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
Subjects who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
Subjects who report receiving any investigational drug within 28 days prior to Period I dosing.
Subjects who report taking any systemic prescription medication in the 14 days prior to Period I dosing.
Subjects who report an intolerance of direct venipuncture.
Subjects who report consuming an abnormal diet during the 28 days prior to Period I dosing.

Trial locations and contacts

1 site in 1 country.

United States1 site

PRACS Institute, Ltd.
Fargo, North Dakota, 58104

Other trials in United States

About this study

Official title: A Relative Bioavailability Study of 15 mg Mirtazapine Orally Disintegrating Tablets Under Fasting Conditions

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions: Healthy
Being tested: Mirtazapine 15 mg (Orally Disintegrating) Tablets, REMERON SolTab® 15 mg Orally Disintegrating Tablets
Keywords: Bioequivalence, Healthy Subjects

What participants receive

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

Mirtazapine 15 mg (Orally Disintegrating) TabletsDrug
1 x 15 mg, single-dose fasting
REMERON SolTab® 15 mg Orally Disintegrating TabletsDrug
1 x 15 mg, single-dose fasting

Study groups in NCT00835575
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Mirtazapine 15 mg (Orally Disintegrating) Tablets
2	Active comparator	Not described Receives: Drug: REMERON SolTab® 15 mg Orally Disintegrating Tablets

What is being measured

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

Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Bioequivalence based on Cmax.
Measured: Blood samples collected over a 120 hour period.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Bioequivalence based on AUC0-t.
Measured: Blood samples collected over a 120 hour period.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Bioequivalence based on AUC0-inf.
Measured: Blood samples collected over a 120 hour period.

Timeline

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

Jul 2003Aug 2003

First posted3 Feb 2009 (estimated)
Study startJul 2003
Primary completionAug 2003
Study completionAug 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00835575
Sponsor's protocol ID: R03-338
Status last verified: Aug 2024
First submitted: 30 Jan 2009
Last updated: 20 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Relative Bioavailability Study of 15 mg Mirtazapine Orally Disintegrating Tablets Under Fasting Conditions
ClinicalTrials.gov ID: NCT00835575
Acronym / sponsor ID: R03-338
Conditions: Healthy
Keywords: Bioequivalence, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Jul 2003
Primary completion: Aug 2003 (actual)
Study completion: Aug 2003 (actual)
First posted: 3 Feb 2009 (estimated)
Results: Posted 18 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Mirtazapine 15 mg (Orally Disintegrating) Tablets
2	Active comparator	Drug: REMERON SolTab® 15 mg Orally Disintegrating Tablets

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Screening Demographics: All subjects selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The subject's body mass index (BMI) should be less than or equal to 30.
Screening Procedures: Each subject will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before fill implementation of screening procedures.
Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
The screening clinical laboratory will include:
If female and:

Key exclusion criteria (17 listed)

Subjects with a recent history of drug or alcohol addiction or abuse.
Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
Subjects demonstrating a positive hepatitis B surface antigen screen, hepatitis C antibody screen, or a reactive HIV antibody screen.
Subjects demonstrating a positive pregnancy screen.

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
Mirtazapine 15 mg (Orally Disintegrating) Tablets1 x 15 mg, single-dose fasting	Drug	1
REMERON SolTab® 15 mg Orally Disintegrating Tablets1 x 15 mg, single-dose fasting	Drug	2

Primary outcome

Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Time frame: Blood samples collected over a 120 hour period.
Bioequivalence based on Cmax.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Time frame: Blood samples collected over a 120 hour period.
Bioequivalence based on AUC0-t.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Time frame: Blood samples collected over a 120 hour period.
Bioequivalence based on AUC0-inf.

Results and safety

Results posted to the registry on 18 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test (Mirtazapine) First	16	16
Reference (Remeron®) First	16	16

Primary outcome: Cmax (Maximum Observed Concentration of Drug Substance in Plasma)

Time frame: Blood samples collected over a 120 hour period.. Mean (Standard Deviation). Unit: pg/mL

Measure	Test (Mirtazapine) n = 31	Reference (Remeron®) n = 31
Value	32975.95 (11873.83)	33122.52 (11246.45)

Test (Mirtazapine) vs Reference (Remeron®): Ratio of the T/R geometric mean x 100: 99.52 (90% CI 92.84 to 106.69)

Population analysed: All participants that completed the study had their samples analyzed.

Primary outcome: AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Time frame: Blood samples collected over a 120 hour period.. Mean (Standard Deviation). Unit: pg*h/mL

Measure	Test (Mirtazapine) n = 31	Reference (Remeron®) n = 31
Value	303749.52 (104877.35)	294920.42 (105344.06)

Test (Mirtazapine) vs Reference (Remeron®): Ratio of the T/R geometric mean x 100: 103.59 (90% CI 99.13 to 108.25)

Population analysed: All participants that completed the study had their samples analyzed.

Primary outcome: AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)

Time frame: Blood samples collected over a 120 hour period.. Mean (Standard Deviation). Unit: pg*h/mL

Measure	Test (Mirtazapine) n = 31	Reference (Remeron®) n = 31
Value	327022.65 (109980.75)	316863.06 (111509.8)

Test (Mirtazapine) vs Reference (Remeron®): Ratio of the T/R geometric mean x 100: 103.87 (90% CI 99.47 to 108.46)

Population analysed: All participants that completed the study had their samples analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

James D. Carlson, Pharm. D. principal investigator

PRACS Institue, Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 inclusion and 17 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 20 Aug 2024. 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.

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?

Yes. Results are posted in the registry (first posted 18 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cmax (Maximum Observed Concentration of Drug Substance in Plasma) (time frame: Blood samples collected over a 120 hour period.). The study lists 3 primary outcomes in all. 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 NCT00835575.

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 20 Aug 2024.