HealthyPhase 1NCT01581866
Bioequivalence Study of Ziprasidone HCL Capsules, 20 mg Under Fasting Conditions
A Phase 1 study testing Ziprasidone Hydrochloride in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in United States.
Trial summary
The objective of this study is to compare the rate and extent of absorption of ziprasidone 20 mg capsules versus Geodon 20 mg capsules under fasting conditions. 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?
- Ziprasidone Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Jan 2005
- 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
- Male or female, smoker or non-smoker, 18 years of age and older.
- Capable of consent.
- BMI between 19.0 and 30.0 kg/m2 inclusively.
Who cannot join
- Clinically significant illnesses within 4 weeks prior to the administration of the study medication.
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- Any clinically significant abnormality found during medical screening.
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
- Positive testing for hepatitis B, hepatitis C, or HIV at screening.
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- ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 100 or over 140 mmHg, diastolic blood pressure lower than 60 or over 90 mmHg, or heart rate less than 60 or over 100 bpm) at screening.
- Qtc > 430 for males and Qtc > 450 for females.
- History of significant alcohol abuse or drug abuse within one year prior to the screening visit.
- Regular use of alcohol within six months prior to the screening visit ( more than fourteen units of alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
- Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
- History of allergic reaction to heparin, ziprasidone, or other related drugs.
- Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazole, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
- Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
- Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms(e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
- Any clinically significant history or presence of clinically significant neurological endocrinal cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
- Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption and hormonal contraceptives.
- Difficulty to swallow study medication.
- Smoking more than 25 cigarettes per day.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the Medical Sub-Investigator, could contraindicate the subject's participation in this study.
- A depot injection or an implant of any drug (other than hormonal contraceptives) within 3 months prior to administration of study medication.
- Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows.
- 50 mL to 300 mL of whole blood within 30 days,
- 301 mL to 500 mL of whole blood within 45 days, or
- more than 500 mL of whole blood within 56 days prior to drug administration.
- Consumption of food or beverages containing grapefruit (e.g. fresh, canned, or frozen) within 7 days prior to administration of the study medication.
- History or known presence of tardive dyskinesia.
- History of neuroleptic malignant syndrome.
- History or known presence of clinically significant cardiac diseases (such as heart failure, QT prolongation, congenital long QT syndrome, myocardial infarction, cardiac arrhythmias, conduction abnormalities) or other conditions such as electrolyte disturbance, hypokalemia or hypomagnesemia.
- Breast-feeding subject.
- Positive urine pregnancy test at screening.
- Female subjects of childbearing potential having unprotected sexual intercourse with any non-steril male partner (i.e male who has not been sterilized by vasectomy for at least 6 months ) within 14 days prior to study drug administration. Acceptable methods of contraception.
- intra-uterine contraceptive device (placed at least 4 weeks prior to study drug administration;
- condom or diaphragm + spermicide;
- hormonal contraceptives (starting at least 4 weeks prior to study drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, 2-way Crossover, Bioequivalence Study of Ziprasidone HCL Capsules, 20 mg in Healthy Subjects Under Fasting Conditions.
The objective of this study is to compare the rate and extent of absorption of ziprasidone 20 mg capsules versus Geodon 20 mg capsules under fasting conditions.
Read the detailed description
Randomized, 2-way crossover, bioequivalence study of Ziprasidone 20 mg capsules and Geodon 20 mg capsules in healthy subjects under fasting conditions.
- Conditions
- Healthy
- Being tested
- Ziprasidone Hydrochloride
- Keywords
- Bioequivalence, Ziprasidone hydrochloride, crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ziprasidone HydrochlorideDrug
Also called Geodon
Ziprasidone HCL Capsules, 20 mg
| Study group | Role | What they receive |
|---|---|---|
| Ziprasidone HCL Capsules, 20 mg | Experimental | Ziprasidone HCL Capsules, 20 mg of Dr. Reddy's Laboratories Limited Receives: Drug: Ziprasidone Hydrochloride |
| Geodon Capsules, 20 mg | Experimental | Geodon Capsules, 20 mg of Pfizer Inc Receives: Drug: Ziprasidone Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC)
Measured: 1, 2, 3, 3.50, 4, 4.50, 5, 5.50, 6, 6.50, 7, 8, 9, 10, 12, 16, 24 and 36 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 posted20 Apr 2012 (estimated)
- Study startNov 2004
- Primary completionNov 2004
- Study completionJan 2005
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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio R. Pizarro, MD, Principal investigator, SFBC Ft. Myers, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581866
- Sponsor's protocol ID
- 40349
- Status last verified
- Apr 2012
- First submitted
- 19 Apr 2012
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, 2-way Crossover, Bioequivalence Study of Ziprasidone HCL Capsules, 20 mg in Healthy Subjects Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT01581866
- Acronym / sponsor ID
- 40349
- Conditions
- Healthy
- Keywords
- Bioequivalence, Ziprasidone hydrochloride, crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Nov 2004 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 20 Apr 2012 (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 rate and extent of absorption of ziprasidone 20 mg capsules versus Geodon 20 mg capsules under fasting conditions.
Detailed description
Randomized, 2-way crossover, bioequivalence study of Ziprasidone 20 mg capsules and Geodon 20 mg capsules in healthy 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 |
|---|---|---|
| Ziprasidone HCL Capsules, 20 mg | Experimental | Drug: Ziprasidone HydrochlorideZiprasidone HCL Capsules, 20 mg of Dr. Reddy's Laboratories Limited |
| Geodon Capsules, 20 mg | Experimental | Drug: Ziprasidone HydrochlorideGeodon Capsules, 20 mg of Pfizer Inc |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female, smoker or non-smoker, 18 years of age and older.
- Capable of consent.
- BMI between 19.0 and 30.0 kg/m2 inclusively.
Key exclusion criteria (35 listed)
- Clinically significant illnesses within 4 weeks prior to the administration of the study medication.
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- Any clinically significant abnormality found during medical screening.
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
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 |
|---|---|---|
| Ziprasidone HydrochlorideAlso: GeodonZiprasidone HCL Capsules, 20 mg | Drug | Geodon Capsules, 20 mg, Ziprasidone HCL Capsules, 20 mg |
Primary outcome
Area under curve (AUC)
Time frame: 1, 2, 3, 3.50, 4, 4.50, 5, 5.50, 6, 6.50, 7, 8, 9, 10, 12, 16, 24 and 36 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 20 Apr 2012.
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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.
Antonio R. Pizarro, MD principal investigator
SFBC Ft. Myers, Inc
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 Ziprasidone Hydrochloride in people with Healthy, run by Dr. Reddy's 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 3 inclusion and 35 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 Apr 2012. 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?
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, 2, 3, 3.50, 4, 4.50, 5, 5.50, 6, 6.50, 7, 8, 9, 10, 12, 16, 24 and 36 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 20 Apr 2012.