HealthyPhase 1NCT01511705
Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fasting Condition
A Phase 1 study testing Ondansetron Hydrochloride in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
This is an open label, balanced, randomized, two-treatment, two-period, two sequence,single dose, crossover, oral bioequivalence study. 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?
- Ondansetron Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2006to Oct 2006
- 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
- Subjects who provide written informed consent.
- Subjects who were healthy adults within 18 and 45 years of age (both inclusive).
- Body mass index of ≥ 18 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
- Subjects who had normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period I.
- Had normal ECG, Chest X-ray and vital signs
- Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
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- If subject is a female volunteer and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s),such as condoms, 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 has been performed on the subject)
- Each female subject were supposed to undergo a urine pregnancy test to check-in for period-I, period-II and post study.
Who cannot join
- Subjects incapable of understanding the informed consent.
- Subjects BP ≤ 9060 mm/Hg or BP ≥ 140/90 mm/Hg.
- History of hypersensitivity or idiosyncratic reaction to ondansetron or any other related drugs.
- Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function. Subjects with a history of tuberculosis, epilepsy, asthma(during past 5 years), diabetes, psychosis or glaucoma were not eligible for the study.
- Regular smoker who smokes more than ten cigarettes daily and has difficulty in abstaining from smoking for the duration of each study period.
- Subjects who has taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication with the past 30 days prior to dosing in Period-I.
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- History of any psychiatric illness, which may impair the ability to provide written informed consent.
- Subjects who have a history of alcohol or substance abuse within the last 5 years.
- Subjects with clinically significant abnormal values of laboratory parameters.
- Subjects who have participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
- Subjects who are unable to or likely to be non-complaint with protocol requirements or restrictions.
- Any subject in whom ondansetron is contraindicated for medical reasons.
- Subjects who are intolerant to venipuncture.
- Subjects with positive urine screen for drugs of abuse. All subjects urine samples assayed for the presence of drugs of abuse at each study period check-in. Subjects who found to have urine concentrations of any of the tested drugs were not allowed to participate.
- Female volunteers who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives with 14 days before dosing.
- Female volunteers who are not negative in pregnancy test
- All female subjects were to be screened for pregnancy at check in of each study period. Subjects with positive or inconclusive results were to be withdrawn from the study.
- Female volunteers who are currently breast feeding.
- Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study were not to be allowed to participate. Female subjects of child bearing potential must either abstain form sexual intercourse or use a reliable barrier method (e.g condom, IUD) or contraception during the course of the study (first dosing until last blood collection) or they were not to be allowed to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Oral Bioequivalence Study of Ondansetron Hydrochloride Tablets 8 mg With Zofran® (Containing Ondansetron Hydrochloride Dihydrate) Tablets 8 mg in Healthy, Adult, Human Subjects Under Fasting Condition.
This is an open label, balanced, randomized, two-treatment, two-period, two sequence,single dose, crossover, oral bioequivalence study.
Read the detailed description
The study was an open label, balanced, randomized, two-treatment, two-period, two sequence,single dose, crossover, oral bioequivalence study of Ondansetron Hydrochloride tablets 8 mg of Dr. Reddy's Laboratories Limited, India comparing with that of Zofran® (containing Ondansetron Hydrochloride Dihydrate) tablets 8 mg of GlaxoSmithKline, USA in healthy, adult, human subjects under fasting condition. 26 subjects are enrolled in the study, and 24 subjects are completed the study.
- Conditions
- Healthy
- Being tested
- Ondansetron Hydrochloride
- Keywords
- Bioequivalence, Ondansetron, crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron HydrochlorideDrug
Also called Ondansetron Hydrochloride 8 mg (Dr. Reddy's Laboratories)
Ondansetron Hydrochloride Tablets 8 mg
Ondansetron HydrochlorideDrug
Zofran Tablets 8 mg
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron Hydrochloride Tablets 8 mg | Experimental | Ondansetron Hydrochloride Tablets 8 mg of Dr. Reddy's Laboratories Limited Receives: Drug: Ondansetron Hydrochloride |
| Zofran Tablets 8 mg | Active comparator | Zofran Tablets 8 mg of GlaxoSmithKline Receives: Drug: Ondansetron Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area unde curve (AUC)
Measured: First one was within 1 hour prior to drug administration (0.0) and others at 0.33,0.67,1,1.33, 1.67, 2, 2.5, 3, 3.5,4,6,9,12,15,18 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startOct 2006
- Primary completionOct 2006
- Study completionOct 2006
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)
- Responsible party
- Sponsor
- Investigators
- Dr. I.S Gandhi, Principal investigator, Vimta Labs Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511705
- Sponsor's protocol ID
- 3873/06-07
- Status last verified
- Oct 2006
- First submitted
- 13 Jan 2012
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Oral Bioequivalence Study of Ondansetron Hydrochloride Tablets 8 mg With Zofran® (Containing Ondansetron Hydrochloride Dihydrate) Tablets 8 mg in Healthy, Adult, Human Subjects Under Fasting Condition.
- ClinicalTrials.gov ID
- NCT01511705
- Acronym / sponsor ID
- 3873/06-07
- Conditions
- Healthy
- Keywords
- Bioequivalence, Ondansetron, 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
- Oct 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 19 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.
This is an open label, balanced, randomized, two-treatment, two-period, two sequence,single dose, crossover, oral bioequivalence study.
Detailed description
The study was an open label, balanced, randomized, two-treatment, two-period, two sequence,single dose, crossover, oral bioequivalence study of Ondansetron Hydrochloride tablets 8 mg of Dr. Reddy's Laboratories Limited, India comparing with that of Zofran® (containing Ondansetron Hydrochloride Dihydrate) tablets 8 mg of GlaxoSmithKline, USA in healthy, adult, human subjects under fasting condition. 26 subjects are enrolled in the study, and 24 subjects are completed the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron Hydrochloride Tablets 8 mg | Experimental | Drug: Ondansetron HydrochlorideOndansetron Hydrochloride Tablets 8 mg of Dr. Reddy's Laboratories Limited |
| Zofran Tablets 8 mg | Active comparator | Drug: Ondansetron HydrochlorideZofran Tablets 8 mg of GlaxoSmithKline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subjects who provide written informed consent.
- Subjects who were healthy adults within 18 and 45 years of age (both inclusive).
- Body mass index of ≥ 18 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
- Subjects who had normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period I.
- Had normal ECG, Chest X-ray and vital signs
Key exclusion criteria (19 listed)
- Subjects incapable of understanding the informed consent.
- Subjects BP ≤ 9060 mm/Hg or BP ≥ 140/90 mm/Hg.
- History of hypersensitivity or idiosyncratic reaction to ondansetron or any other related drugs.
- Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function. Subjects with a history of tuberculosis, epilepsy, asthma(during past 5 years), diabetes, psychosis or glaucoma were not eligible for the study.
- Regular smoker who smokes more than ten cigarettes daily and has difficulty in abstaining from smoking for the duration of each study period.
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 |
|---|---|---|
| Ondansetron HydrochlorideAlso: Ondansetron Hydrochloride 8 mg (Dr. Reddy's Laboratories)Ondansetron Hydrochloride Tablets 8 mg | Drug | Ondansetron Hydrochloride Tablets 8 mg |
| Ondansetron HydrochlorideZofran Tablets 8 mg | Drug | Zofran Tablets 8 mg |
Primary outcome
Area unde curve (AUC)
Time frame: First one was within 1 hour prior to drug administration (0.0) and others at 0.33,0.67,1,1.33, 1.67, 2, 2.5, 3, 3.5,4,6,9,12,15,18 and 24 hours
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 19 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.
Dr. I.S Gandhi principal investigator
Vimta Labs Limited
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 Ondansetron Hydrochloride in people with Healthy, 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 11 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 19 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?
Area unde curve (AUC) (time frame: First one was within 1 hour prior to drug administration (0.0) and others at 0.33,0.67,1,1.33, 1.67, 2, 2.5, 3, 3.5,4,6,9,12,15,18 and 24 hours). 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 19 Jan 2012.