FastingPhase 1NCT01884857
Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 50 mg
A Phase 1 study testing Metoprolol Succinate ER Tablets 50 mg and 'TOPROL-XL®' ER Tablets 50 mg in people with Fasting, run by IPCA Laboratories Ltd. at 1 site in India.
Trial summary
This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in healthy adult human subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- Metoprolol Succinate ER Tablets 50 mg and 'TOPROL-XL®' ER Tablets 50 mg
- 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
- Apr 2013to Jun 2013
- 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
- 18 to 45 years old, both inclusive.
- Sex: Males and/or non-pregnant, non-lactating females.
- BMI: 18.5 to 24.9 weight in kg/(height in meter)2 both inclusive;
- Able to communicate effectively with study personnel and willingness to follow the protocol requirements as evidenced by written informed consent.
- Able to give written informed consent to participate in the study.
- All volunteers must be judged by the principal or co-investigator or physician as normal and healthy during a pre-study safety assessment performed within 21 days of the first dose of study medication which will include:
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- A physical examination with no clinically significant finding.
- Results within normal limits or clinically non-significant for the tests mentioned in List of Laboratory Parameters:
- Additional tests and/or examinations may be performed, if necessary, based on Principal Investigator discretion.
- All results will be assessed against the laboratory normal ranges current at the time of testing and a copy of the normal ranges used will be included in the study documentation.
Who cannot join
- History of allergic responses to Metoprolol Succinate or other related drugs, or any of its formulation ingredients.
- Have significant diseases or clinically significant abnormal findings during screening, [medical history, physical examination, laboratory evaluations, ECG, chest X-ray recording, obstetrics and gynecological history and examination along with PAP smear (for female volunteers) \& transvaginal ultrasonography (for female volunteers)].
- Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
- History or presence of bronchial asthma.
- Use of any hormone replacement therapy within 3 months prior to study medication dosing.
- A depot injection or implant of any drug within 3 months prior to administration of study medication.
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- Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
- History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
- Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period.
- History of difficulty with donating blood or difficulty in accessibility of veins.
- History of allergic response to heparin.
- A positive hepatitis screen (includes subtypes B \& C).
- A positive test result for HIV antibody and / or syphilis (RPR/VDRL).
- Volunteers who have donated blood (1 unit or 450 mL) within 90 days prior to the initial dose of the study drug or have blood loss, excluding volume drawn at screening for this study, (≤100 mL within 30 days; ≤200 mL within 60 days; >200 mL within 90 days) prior to initial dose of study drug.
- History of difficulty in swallowing, or of any gastrointestinal disease which could affect drug absorption.
- Intolerance to venipuncture
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Co-Investigator, could contraindicate the volunteer's participation in this study.
- Volunteers who have received a known investigational drug within five elimination half life of the administered drug prior to the initial dose of study drug or who have participated in a clinical drug study or bioequivalence study within 90 days prior to the initial dose of study drug, whichever is greater.
- Found positive in urine test for drugs of abuse done before check-in of period I.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Crossover, Balanced, Single Dose Oral Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 50 mg of Ipca Laboratories Limited, India and 'Toprol-XL®' (Metoprolol Succinate) Extended Release Tablets 50 mg of Astrazeneca LP, USA In Healthy Adult Human Subjects Under Fasting Conditions
This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in healthy adult human subjects.
Read the detailed description
Objective of this pivotal study was to assess the bioequivalence between Test Product: Metoprolol Succinate 50 mg Ipca Laboratories Limited, India and the corresponding Reference Product: TOPROL-XL® (Metoprolol Succinate) extended release Tablets 50 mg of Astrazenica LP, USA under fasting condition in healthy adult human subjects in a randomized crossover study.
The study was conducted with 48 healthy adult subjects. In each study period, a single 50 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 approximately 11 days including washout period of at least 7 days between administrations of study drug in each study period.
- Conditions
- Fasting
- Being tested
- Metoprolol Succinate ER Tablets 50 mg, 'TOPROL-XL®' ER Tablets 50 mg
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoprolol Succinate ER Tablets 50 mgDrug
Also called Test Product
1* 50 mg tablet once a day
'TOPROL-XL®' ER Tablets 50 mgDrug
Also called Reference Product
1 * 50 mg tablet per day
| Study group | Role | What they receive |
|---|---|---|
| 'TOPROL-XL®' ER Tablets 50 mg | Active comparator | 'TOPROL-XL®' ER Tablets 50 mg of Astrazeneca LP, USA Receives: Drug: Metoprolol Succinate ER Tablets 50 mg; Drug: 'TOPROL-XL®' ER Tablets 50 mg |
| Metoprolol Succinate ER Tablets 50 mg | Experimental | Metoprolol Succinate ER Tablets 50 mg of Ipca Laboratories Limited, India Receives: Drug: Metoprolol Succinate ER Tablets 50 mg; Drug: 'TOPROL-XL®' ER Tablets 50 mg |
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 1.0, 2.0, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0,11.0, 12.0, 13.0, 14.0, 16.0, 20.0, 24.0, 36.0 and 48.0 hours post dose.
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 posted24 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies 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
- IPCA Laboratories Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Manish Singhal, MBBS, Principal investigator, Cliantha Research Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884857
- Sponsor's protocol ID
- BA1264349
- Status last verified
- Jun 2013
- First submitted
- 19 Jun 2013
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Crossover, Balanced, Single Dose Oral Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 50 mg of Ipca Laboratories Limited, India and 'Toprol-XL®' (Metoprolol Succinate) Extended Release Tablets 50 mg of Astrazeneca LP, USA In Healthy Adult Human Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01884857
- Acronym / sponsor ID
- BA1264349
- Conditions
- Fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- IPCA Laboratories Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 24 Jun 2013 (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, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in healthy adult human subjects.
Detailed description
Objective of this pivotal study was to assess the bioequivalence between Test Product: Metoprolol Succinate 50 mg Ipca Laboratories Limited, India and the corresponding Reference Product: TOPROL-XL® (Metoprolol Succinate) extended release Tablets 50 mg of Astrazenica LP, USA under fasting condition in healthy adult human subjects in a randomized crossover study.
The study was conducted with 48 healthy adult subjects. In each study period, a single 50 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 approximately 11 days including washout period of at least 7 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 |
|---|---|---|
| 'TOPROL-XL®' ER Tablets 50 mg | Active comparator | Drug: Metoprolol Succinate ER Tablets 50 mg, Drug: 'TOPROL-XL®' ER Tablets 50 mg'TOPROL-XL®' ER Tablets 50 mg of Astrazeneca LP, USA |
| Metoprolol Succinate ER Tablets 50 mg | Experimental | Drug: Metoprolol Succinate ER Tablets 50 mg, Drug: 'TOPROL-XL®' ER Tablets 50 mgMetoprolol Succinate ER Tablets 50 mg of Ipca Laboratories Limited, India |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 18 to 45 years old, both inclusive.
- Sex: Males and/or non-pregnant, non-lactating females.
- BMI: 18.5 to 24.9 weight in kg/(height in meter)2 both inclusive;
- Able to communicate effectively with study personnel and willingness to follow the protocol requirements as evidenced by written informed consent.
- Able to give written informed consent to participate in the study.
Key exclusion criteria (19 listed)
- History of allergic responses to Metoprolol Succinate or other related drugs, or any of its formulation ingredients.
- Have significant diseases or clinically significant abnormal findings during screening, [medical history, physical examination, laboratory evaluations, ECG, chest X-ray recording, obstetrics and gynecological history and examination along with PAP smear (for female volunteers) \& transvaginal ultrasonography (for female volunteers)].
- Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
- History or presence of bronchial asthma.
- Use of any hormone replacement therapy within 3 months prior to study medication dosing.
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 |
|---|---|---|
| Metoprolol Succinate ER Tablets 50 mgAlso: Test Product1* 50 mg tablet once a day | Drug | 'TOPROL-XL®' ER Tablets 50 mg, Metoprolol Succinate ER Tablets 50 mg |
| 'TOPROL-XL®' ER Tablets 50 mgAlso: Reference Product1 * 50 mg tablet per day | Drug | 'TOPROL-XL®' ER Tablets 50 mg, Metoprolol Succinate ER Tablets 50 mg |
Primary outcome
Bioequivalence is based on Cmax and AUC parameters.
Time frame: 3 Months
Area Under Curve (AUC)and Cmax Sampling Hours: Pre-dose and at 1.0, 2.0, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0,11.0, 12.0, 13.0, 14.0, 16.0, 20.0, 24.0, 36.0 and 48.0 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 24 Jun 2013.
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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. Manish Singhal, MBBS principal investigator
Cliantha Research 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 Metoprolol Succinate ER Tablets 50 mg and 'TOPROL-XL®' ER Tablets 50 mg in people with Fasting, 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 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 24 Jun 2013. 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: 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 24 Jun 2013.