Fasting StatePhase 1NCT01603134
Bioequivalence Study of Allopurinol 300 mg Tablets USP Under Fasting Condition
A Phase 1 study testing Allopurinol in people with Fasting State, run by IPCA Laboratories Ltd. at 1 site in India.
Trial summary
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over comparative pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, human male… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fasting State
- What is being tested?
- Allopurinol
- 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 siteIndia
- Study dates
- Nov 2007to Apr 2008
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects in the range of 18 - 45 years of age (Inclusive).
- The healthy human male subjects, whose body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.
- Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).
- Subjects with normal findings, as determined by hematological tests, serum biochemistry, urine analysis, ECG and X-ray (if required).
- Willingness to follow the protocol requirements as evidenced by written informed consent.
- Agreeing to, not using any medication(either prescribed, OTC or alternate medicines), including vitamins and minerals for 14 days prior to study and during the course of the study.
- No history or presence of significant alcoholism in the past one year.
- Non-smokers, ex-smokers and light smokers will be included. "Light smokers are defined as someone smoking 10 cigarettes or less per day, ex-smokers as someone who completely stopped smoking for at least 3 months.
Who cannot join
- Requiring medication for any ailment including enzyme-modifying drugs in the previous 28 days, before day one (1) of dosing.
- Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
- Subjects with history of recent myocardial infraction, cardiac arrhythmias, cardiac failure and convulsions.
- Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
- History of malignancy or other serious diseases.
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- Refusal to abstain from food for at least ten (10.00) hours prior to administration of study drug and for at least four (04.00) hours post-dose.
- Refusal to abstain from water for at least one (01.00) hour prior to study drug administration of each study period and for at least two (02.00) hours post-dose except about 240 mL administered during administration dose.
- Any contraindication with blood sampling.
- Refusal to abstain from smoking or consumption of tobacco products 48.00 hours before dosing until the last sample collection of each period.
- Found positive in breath alcohol test done at the time of check-in for each study period.
- History of drug abuse in past one year.
- Use of xanthine-containing beverages or food, and fruit juice or grapefruit juice products for 48.00 hours prior to each drug dose.
- Blood donation 90 days prior to the commencement of the study.
- Subjects with positive HBsAg or Hepatitis-C, HIV tests and anti Treponema Palladium/Syphilis test.
- History of hypersensitivity to Allopurinol or any ingredients of formulation.
- History of problem in swallowing Tablet(s).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Two-Period, Two-Treatment, Two-Sequence, Single Dose, Crossover Comparative Bioequivalence Study of Allopurinol 300 mg Tablets USP With Zyloprim® 300 mg in Normal, Healthy, Adult, Human Male Subjects Under Fasting Condition.
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over comparative pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, human male subjects.
Read the detailed description
Objective of this pivotal study was to assess the bioequivalence between Test Product: Allopurinol 300 mg Tablets USP of M/s Ipca Laboratories Limited, India and the corresponding Reference Product: Zyloprim® (Allopurinol) 300 mg Tablets manufactured by Catalytica Pharma Inc., USA for Prometheus Laboratories Inc., USA, under fasting condition in normal, healthy, adult, human male subjects in a randomized crossover study.
The study was conducted with 32 healthy adult male subjects. In each study period, a single 300 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.
The duration of the clinical phase was 51 days including washout period of at 18 days between administrations of study drug in each study period.
- Conditions
- Fasting State
- Being tested
- Allopurinol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
Also called Test Product
300 mg tablet once a day
AllopurinolDrug
Also called Zyloprim®
300 mg tablet once a day
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol 300 mg Tablets USP | Experimental | Allopurinol 300 mg Tablets USP of M/s Ipca Laboratories Limited, India Receives: Drug: Allopurinol |
| Zyloprim® | Active comparator | Zyloprim® (Allopurinol) 300 mg Tablets manufactured by Catalytica Pharma Inc., USA for Prometheus Laboratories Inc., USA, Receives: Drug: Allopurinol |
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.
Area Under Curve (AUC) and Cmax Sampling Hours: Pre-dose and at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 02.75, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 08.00, 10.00, 12.00, 16.00, 24.00, 48.00, 72.00 and 96.00 hours post-dose.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startNov 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasting StateStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- IPCA Laboratories Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Nirav Gandhi, M.D., Principal investigator, Accutest Research Lab (I) Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603134
- Sponsor's protocol ID
- Ipca/US/07/030
- Status last verified
- May 2012
- First submitted
- 18 May 2012
- Last updated
- 22 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Two-Period, Two-Treatment, Two-Sequence, Single Dose, Crossover Comparative Bioequivalence Study of Allopurinol 300 mg Tablets USP With Zyloprim® 300 mg in Normal, Healthy, Adult, Human Male Subjects Under Fasting Condition.
- ClinicalTrials.gov ID
- NCT01603134
- Acronym / sponsor ID
- Ipca/US/07/030
- Conditions
- Fasting State
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- IPCA Laboratories Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 22 May 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.
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over comparative pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, human male subjects.
Detailed description
Objective of this pivotal study was to assess the bioequivalence between Test Product: Allopurinol 300 mg Tablets USP of M/s Ipca Laboratories Limited, India and the corresponding Reference Product: Zyloprim® (Allopurinol) 300 mg Tablets manufactured by Catalytica Pharma Inc., USA for Prometheus Laboratories Inc., USA, under fasting condition in normal, healthy, adult, human male subjects in a randomized crossover study.
The study was conducted with 32 healthy adult male subjects. In each study period, a single 300 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.
The duration of the clinical phase was 51 days including washout period of at 18 days between administrations of study drug in each study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allopurinol 300 mg Tablets USP | Experimental | Drug: AllopurinolAllopurinol 300 mg Tablets USP of M/s Ipca Laboratories Limited, India |
| Zyloprim® | Active comparator | Drug: AllopurinolZyloprim® (Allopurinol) 300 mg Tablets manufactured by Catalytica Pharma Inc., USA for Prometheus Laboratories Inc., USA, |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male subjects in the range of 18 - 45 years of age (Inclusive).
- The healthy human male subjects, whose body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.
- Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).
- Subjects with normal findings, as determined by hematological tests, serum biochemistry, urine analysis, ECG and X-ray (if required).
- Willingness to follow the protocol requirements as evidenced by written informed consent.
Key exclusion criteria (17 listed)
- Requiring medication for any ailment including enzyme-modifying drugs in the previous 28 days, before day one (1) of dosing.
- Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
- Subjects with history of recent myocardial infraction, cardiac arrhythmias, cardiac failure and convulsions.
- Participation in a clinical drug study or bioequivalence study 90 days prior to present 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 |
|---|---|---|
| AllopurinolAlso: Test Product300 mg tablet once a day | Drug | Allopurinol 300 mg Tablets USP |
| AllopurinolAlso: Zyloprim®300 mg tablet once a day | Drug | Zyloprim® |
Primary outcome
Bioequivalence is based on Cmax and AUC parameters.
Time frame: 6 months
Area Under Curve (AUC) and Cmax Sampling Hours: Pre-dose and at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 02.75, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 08.00, 10.00, 12.00, 16.00, 24.00, 48.00, 72.00 and 96.00 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 22 May 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.
Dr. Nirav Gandhi, M.D. principal investigator
Accutest Research Lab (I) Pvt. 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 Allopurinol in people with Fasting State, run by IPCA Laboratories Ltd. 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 8 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 22 May 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: 6 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 22 May 2012.