HealthyPhase 1NCT01627886
Bioequivalence Study of Ibandronate Sodium Tablets 150 mg Under Fasting Condition
A Phase 1 study testing Ibandronate sodium in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ibandronate sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2008to Oct 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 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subjects should be healthy human of 18 years or older.
- The subjects should be screened within 21 days prior to the administration of first dose of the study drug.
- The subjects should have a BMI between 19 and 30 weight in kg/ height2 in meter.
- The subjects should be able to communicate effectively with study personnel.
- The subjects should be able to give written informed consent to participate in the study.
- If subject is a female volunteer and
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- 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 surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject) or
- Should be postmenopausal healthy women who have attained complete menopause and have not had menstruation for at least one year and are not on hormone replacement therapy.
- Should have 17ß-estradiol serum levels of ≤92 pmol/L, follicle stimulating hormone (FSH) of ≥40 IU/L during the screening (only for postmenopausal healthy women)
Who cannot join
- The subjects who have a history of allergic responses to Ibandronate or other related drugs.
- The subjects who have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination, laboratory evaluations, ECG, X-ray and vaginal ultrasonography recordings (only for female subjects)]
- The subjects who have any disease or condition which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
- The subjects who have a history or presence of bronchial asthma.
- The subject who have used enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
- The subjects who have history of drug dependence, recent history of alcoholism or of moderate alcohol uses.
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- The subjects who are smokers who smoke more than or equal to 10 cigarettes per day or more than or equal to 20 biddies per day or those who can not refrain from smoking during study period.
- The subjects with a history of difficulty with donating blood or difficulty in accessibility of veins.
- The subjects who have donated 1 unit (350 ml / 450 ml) blood within 90 days prior to receiving the first dose of study medication.
- The subjects who have a positive hepatitis screen (includes subtypes A, B, C \& E).
- The subjects who have a positive test result for HIV antibody and / or syphilis (RPR/VDRL).
- The subject who receives an investigational product, or has participated in a drug research study within a period of 90 days prior to the first dose of the study medication administration.
- Female volunteers demonstrating a positive pregnancy screen.
- Female volunteers who are currently breast-feeding.
- Female volunteers not willing to use contraception during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, Balanced, Randomized,Two-Treatment, Two-Sequence, Two-Period, Single-Dose, Crossover Oral Bioequivalence Study Of Ibandronate Sodium 150 mg Tablets Of Dr. Reddy's Laboratories Limited, India and 'BONIVA®' 150 mg (Ibandronate Sodium) Tablets Of Roche Laboratories Inc., USA In Healthy, Adult, Human Subjects Under Fasting Conditions.
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study.
Read the detailed description
Open-Label, Balanced, Randomized,Two-Treatment, Two-Sequence, Two-Period, Single-Dose, Crossover Oral Bioequivalence Study Of Ibandronate Sodium 150 mg Tablets Of Dr. Reddy's Laboratories Limited, India And 'BONIVA®' 150 mg (Ibandronate Sodium)Tablets Of Roche Laboratories Inc., USA In Healthy, Adult, Human Subjects Under Fasting Conditions (With As Many Postmenopausal Women As Possible).
- Conditions
- Healthy
- Being tested
- Ibandronate sodium
- Keywords
- Bioequivalence, Ibandronate Sodium, crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibandronate sodiumDrug
Also called Boniva
Ibandronate sodium Tablets 150 mg
| Study group | Role | What they receive |
|---|---|---|
| Ibandronate sodium tablets 150 mg | Experimental | Ibandronate sodium tablets 150 mg of Dr. Reddy's Laboratories Limited Receives: Drug: Ibandronate sodium |
| Boniva | Active comparator | Boniva Tablets 150 mg of Roche Laboratories Inc, USA Receives: Drug: Ibandronate sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve(AUC)
Measured: Prior to dosing (0.0 hour) and at 0.25, 0.50, 0.75, 1.0, 1.25, 1.50, 2.0, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 24.0, 36.0, 48.0 and 72.0 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 posted26 Jun 2012 (estimated)
- Study startSep 2008
- Primary completionSep 2008
- Study completionOct 2008
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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Simran Sethi, MBBS, Principal investigator, BA Research India Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627886
- Sponsor's protocol ID
- BA0859144-01
- Status last verified
- Nov 2008
- First submitted
- 22 Jun 2012
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Balanced, Randomized,Two-Treatment, Two-Sequence, Two-Period, Single-Dose, Crossover Oral Bioequivalence Study Of Ibandronate Sodium 150 mg Tablets Of Dr. Reddy's Laboratories Limited, India and 'BONIVA®' 150 mg (Ibandronate Sodium) Tablets Of Roche Laboratories Inc., USA In Healthy, Adult, Human Subjects Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT01627886
- Acronym / sponsor ID
- BA0859144-01
- Conditions
- Healthy
- Keywords
- Bioequivalence, Ibandronate Sodium, crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 26 Jun 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, randomised, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study.
Detailed description
Open-Label, Balanced, Randomized,Two-Treatment, Two-Sequence, Two-Period, Single-Dose, Crossover Oral Bioequivalence Study Of Ibandronate Sodium 150 mg Tablets Of Dr. Reddy's Laboratories Limited, India And 'BONIVA®' 150 mg (Ibandronate Sodium)Tablets Of Roche Laboratories Inc., USA In Healthy, Adult, Human Subjects Under Fasting Conditions (With As Many Postmenopausal Women As Possible).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibandronate sodium tablets 150 mg | Experimental | Drug: Ibandronate sodiumIbandronate sodium tablets 150 mg of Dr. Reddy's Laboratories Limited |
| Boniva | Active comparator | Drug: Ibandronate sodiumBoniva Tablets 150 mg of Roche Laboratories Inc, USA |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- The subjects should be healthy human of 18 years or older.
- The subjects should be screened within 21 days prior to the administration of first dose of the study drug.
- The subjects should have a BMI between 19 and 30 weight in kg/ height2 in meter.
- The subjects should be able to communicate effectively with study personnel.
- The subjects should be able to give written informed consent to participate in the study.
Key exclusion criteria (15 listed)
- The subjects who have a history of allergic responses to Ibandronate or other related drugs.
- The subjects who have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination, laboratory evaluations, ECG, X-ray and vaginal ultrasonography recordings (only for female subjects)]
- The subjects who have any disease or condition which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
- The subjects who have a history or presence of bronchial asthma.
- The subject who have used enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
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 |
|---|---|---|
| Ibandronate sodiumAlso: BonivaIbandronate sodium Tablets 150 mg | Drug | Boniva, Ibandronate sodium tablets 150 mg |
Primary outcome
Area under curve(AUC)
Time frame: Prior to dosing (0.0 hour) and at 0.25, 0.50, 0.75, 1.0, 1.25, 1.50, 2.0, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 24.0, 36.0, 48.0 and 72.0 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 28 Jun 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. Simran Sethi, MBBS principal investigator
BA Research India 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 Ibandronate sodium 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 10 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 28 Jun 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 under curve(AUC) (time frame: Prior to dosing (0.0 hour) and at 0.25, 0.50, 0.75, 1.0, 1.25, 1.50, 2.0, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 24.0, 36.0, 48.0 and 72.0 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 28 Jun 2012.