FedPhase 1NCT01503424
Bioequivalence Study of Olanzapine Tablets, 5 mg Under Fed Study
A Phase 1 study testing Olanzapine in people with Fed, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
The purpose of this study is to compare the bioequivalence and characterize the profile of the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects under fed conditions and to monitor the adverse events and ensure the safety of the subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fed
- What is being tested?
- Olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2011to Sep 2011
- 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
- Healthy, adult, human volunteers between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city of western part of IndIa.
- Having a Body Mass Index (BMI) between 18.5 and 24.9(both inclusive), calculated as weight in kg/height in m2.
- Non-smokers since at least six months.
- Have no significant diseases or clinically significant abnormal findings during screening,medical history, clinical examination, laboratory evaluations, 12- lead ECG and X-ray chest (postero-anterior view) recordings.
- Able to understand and comply with the study procedures. in the opinion of the Principal investigator.
- Able to give voluntary written informed consent for participation in the trial.
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- In case of female subjects:
- Surgically sterilized at least 6 months prior to study participation or
- If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
- Pregnancy test must be negative.
Who cannot join
- Known hypersensitivity or idiosyncratic reaction to olanzapine to any of its excipients or any drug or any substance.
- History or presence of any disease or condition which might compromise the haemopoietic,renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- A recent history of harmful use of alcohol(less than 2 years),ie alcohol consumption of more than 14 standard drinks per week for men and 07 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits such as rum, whisky, brandy etc), or consumption of alcohol or alcoholic product within 48 hrs prior to receiving IMP.
- Inability to remain in an upright position at the time of dosing.
- Sitting blood pressure less than 110/70 mm Hg or pulse rate less than 60 or more than 100 beats per minute at the time of screening.
- Presence of orthostatic hypotension at the time of screening.
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- Ingestion or Use of any medication at any time within l4 days prior to dosing in period-1. In any such case subject selection will be at the discretion of the Principal Investigator.
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAII)induced urticaria.
- Consumption of Grape fruits or its products within a period of 48 hours prior to receiving the study drug.
- The presence of clinically significant abnormal laboratory values during screening.
- Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- History or presence of psychiatric disorders.
- A history of difficulty with donating blood.
- Donation of blood (l unit or 350 mL) or receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study.
- Note: In case the blood loss is ≤ 200 mL; subject may be enrolled 60 days after blood donation or last sample of the previous study.
- A positive hepatitis screen including hepatitis B surface antigen and HCV antibodies.
- A positive test result for HIV antibody.
- An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study drug. In any such case subject selection will be at the discretion of the Principal Investigator.
- Nursing mothers (females).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Oral Dose, Crossover, Bioequivalence Study of Olanzapine Tablets 5 mg With Zyprexa® Tablets 5 mg in Healthy Subjects Under Fed Conditions
The purpose of this study is to compare the bioequivalence and characterize the profile of the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects under fed conditions and to monitor the adverse events and ensure the safety of the subjects.
Read the detailed description
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Olanzapine Tablets 5 mg of Dr. Reddy's Laboratories Limited, India, comparing with that of Zyprexa® (Olanzapine) Tablets 5 mg of Eli Lilly and Company, USA, in healthy, adult, human subjects under fed conditions.
- Conditions
- Fed
- Being tested
- Olanzapine
- Medical subject headings
- Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Also called Zyprexa
Olanzapine Tablets, 5 mg
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine Tablets, 5 mg | Experimental | Olanzapine Tablets, 5 mg of Dr. Reddy's Laboratories Limited Receives: Drug: Olanzapine |
| Zyprexa | Active comparator | Zyprexa Tablets, 5 mg of Eli Lilly and company Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence is based on Cmax and AUC parameters
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startAug 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FedStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alpeshkumar Patel, MD, Principal investigator, Lambda Therapeutic Research Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503424
- Sponsor's protocol ID
- 379-11
- Status last verified
- Jan 2012
- First submitted
- 2 Jan 2012
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Oral Dose, Crossover, Bioequivalence Study of Olanzapine Tablets 5 mg With Zyprexa® Tablets 5 mg in Healthy Subjects Under Fed Conditions
- ClinicalTrials.gov ID
- NCT01503424
- Acronym / sponsor ID
- 379-11
- Conditions
- Fed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Jan 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 purpose of this study is to compare the bioequivalence and characterize the profile of the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects under fed conditions and to monitor the adverse events and ensure the safety of the subjects.
Detailed description
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Olanzapine Tablets 5 mg of Dr. Reddy's Laboratories Limited, India, comparing with that of Zyprexa® (Olanzapine) Tablets 5 mg of Eli Lilly and Company, USA, in healthy, adult, human subjects under fed conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olanzapine Tablets, 5 mg | Experimental | Drug: OlanzapineOlanzapine Tablets, 5 mg of Dr. Reddy's Laboratories Limited |
| Zyprexa | Active comparator | Drug: OlanzapineZyprexa Tablets, 5 mg of Eli Lilly and company |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy, adult, human volunteers between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city of western part of IndIa.
- Having a Body Mass Index (BMI) between 18.5 and 24.9(both inclusive), calculated as weight in kg/height in m2.
- Non-smokers since at least six months.
- Have no significant diseases or clinically significant abnormal findings during screening,medical history, clinical examination, laboratory evaluations, 12- lead ECG and X-ray chest (postero-anterior view) recordings.
- Able to understand and comply with the study procedures. in the opinion of the Principal investigator.
Key exclusion criteria (19 listed)
- Known hypersensitivity or idiosyncratic reaction to olanzapine to any of its excipients or any drug or any substance.
- History or presence of any disease or condition which might compromise the haemopoietic,renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- A recent history of harmful use of alcohol(less than 2 years),ie alcohol consumption of more than 14 standard drinks per week for men and 07 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits such as rum, whisky, brandy etc), or consumption of alcohol or alcoholic product within 48 hrs prior to receiving IMP.
- Inability to remain in an upright position at the time of dosing.
- Sitting blood pressure less than 110/70 mm Hg or pulse rate less than 60 or more than 100 beats per minute at the time of screening.
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 |
|---|---|---|
| OlanzapineAlso: ZyprexaOlanzapine Tablets, 5 mg | Drug | Olanzapine Tablets, 5 mg, Zyprexa |
Primary outcome
Bioequivalence is based on Cmax and AUC parameters
Time frame: 2 months
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 5 Jan 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.
Alpeshkumar Patel, MD principal investigator
Lambda Therapeutic Research 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 Olanzapine in people with Fed, 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 10 inclusion and 19 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 5 Jan 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 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?
Bioequivalence is based on Cmax and AUC parameters (time frame: 2 months). 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 5 Jan 2012.