HealthyPhase 1NCT01161927
Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Non- Fasting Conditions
A Phase 1 study testing Nizatidine and Axid in people with Healthy, run by Dr. Reddy's Laboratories Limited.
Trial summary
The purpose of this study is to compare experimental evaluation of relative bioavailabilities in healthy, human subjects under non-fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nizatidine and Axid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Sep 2004
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males between 18 and 55 years of age (inclusive) living in and around Ahmedabad city of western part of India.
- Having a Body Mass Index (BMI) ≥ 18.0 kg/m2 (calculated as weight in kg/ height in m2).
- Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG and X-ray recordings.
- Able to communicate effectively with study personnel. Able to give consent for participation in the trial
Who cannot join
- Known hypersensitivity or idiosyncratic reaction to nizatidine or other related drugs.
- Any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, or any other body system.
- Ingestion of a medication at any time in 14 days before the start of the study. In any such case subject selection will be at the discretion of the Principal Investigator/Medical expert/co-investigator.
- Any history or presence of asthma or nasal polyp.
- A recent history of alcoholism (<2years) or of moderate (180 ml/day) alcohol use.
- Smokers, who smoke more than 10 cigarettes/day or those who cannot refrain from smoking during study period.
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- 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 scan.
- History of psychiatric disorders.
- A history of difficulty with donating blood.
- Donations of blood (1 unit or 450 ml) within 90 days prior to receiving the first dose of study medication. Note: Incase the blood loss is ≤ 200 L, subject may be dosed after completion of 60 days of blood donation).
- A positive hepatitis screen including hepatitis B surface antigen, anti-HCV and anti-HAV antibodies.
- A positive test result for HIV antibody and/or syphilis.
- The receipt of an investigational 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: If subject had participated in a study in which blood loss is ≤200 mL, subject can be dosed after completion of 60 days of previous study).
- An unusual diet, for whatever reason (eg., low-sodium), for four weeks prior to receiving the study medication and throughout the subjects, participation in the study. In any such case subject will be at the discretion of the Principal Investigator/Medical expert/Co-investigator.
About this study
Official title: A Two-way Crossover Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Nizatidine 300 mg Capsules in Healthy Human Subjects Under Non-fasting Conditions
The purpose of this study is to compare experimental evaluation of relative bioavailabilities in healthy, human subjects under non-fasting conditions.
Read the detailed description
Open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, comparative oral bioavailability study in healthy, adult, male human subjects under non-fasting conditions.
- Conditions
- Healthy
- Being tested
- Nizatidine, Axid
- Keywords
- Bioavailability, Nizatidine, Crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NizatidineDrug
Also called Axid 300 mg Capsules
Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited
AxidDrug
Axid 300 mg Capsules of Reliant Pharmaceuticals, US
| Study group | Role | What they receive |
|---|---|---|
| Nizatidine | Experimental | Nizatidine Capsules 300 mg of Dr.Reddy'sLaboratories Limited Receives: Drug: Nizatidine |
| Axid | Active comparator | Axid 300 mg Capsules of Reliant Pharmaceuticals, US Receives: Drug: Axid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax and AUC parameters
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startJul 2004
- Primary completionSep 2004
- Study completionSep 2004
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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Charu Gautam, M.D, Principal investigator, Lambda Therapeutic Research Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161927
- Sponsor's protocol ID
- 003-04
- Status last verified
- Jul 2010
- First submitted
- 13 Jul 2010
- Last updated
- 14 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-way Crossover Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Nizatidine 300 mg Capsules in Healthy Human Subjects Under Non-fasting Conditions
- ClinicalTrials.gov ID
- NCT01161927
- Acronym / sponsor ID
- 003-04
- Conditions
- Healthy
- Keywords
- Bioavailability, Nizatidine, Crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 14 Jul 2010 (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 experimental evaluation of relative bioavailabilities in healthy, human subjects under non-fasting conditions.
Detailed description
Open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, comparative oral bioavailability study in healthy, adult, male human subjects under non-fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nizatidine | Experimental | Drug: NizatidineNizatidine Capsules 300 mg of Dr.Reddy'sLaboratories Limited |
| Axid | Active comparator | Drug: AxidAxid 300 mg Capsules of Reliant Pharmaceuticals, US |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males between 18 and 55 years of age (inclusive) living in and around Ahmedabad city of western part of India.
- Having a Body Mass Index (BMI) ≥ 18.0 kg/m2 (calculated as weight in kg/ height in m2).
- Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG and X-ray recordings.
- Able to communicate effectively with study personnel. Able to give consent for participation in the trial
Key exclusion criteria (15 listed)
- Known hypersensitivity or idiosyncratic reaction to nizatidine or other related drugs.
- Any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, or any other body system.
- Ingestion of a medication at any time in 14 days before the start of the study. In any such case subject selection will be at the discretion of the Principal Investigator/Medical expert/co-investigator.
- Any history or presence of asthma or nasal polyp.
- A recent history of alcoholism (<2years) or of moderate (180 ml/day) alcohol use.
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 |
|---|---|---|
| NizatidineAlso: Axid 300 mg CapsulesNizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited | Drug | Nizatidine |
| AxidAxid 300 mg Capsules of Reliant Pharmaceuticals, US | Drug | Axid |
Primary outcome
Bioequivalence based on Cmax and AUC parameters
Time frame: 3 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 14 Jul 2010.
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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.
Charu Gautam, M.D principal investigator
Lambda Therapeutic Research Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nizatidine and Axid in people with Healthy, run by Dr. Reddy's Laboratories Limited.
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 4 inclusion and 15 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 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
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 based on Cmax and AUC parameters (time frame: 3 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 14 Jul 2010.