HealthyPhase 1NCT01694797
Bioequivalence Study for Metoprolol Succinate ER Tablets 50 mg Under Fasting Condition
A Phase 1 study testing Metoprolol Succinate in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol Succinate Extended-Release Tablets 50 mg under fasting conditions 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?
- Metoprolol Succinate
- 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
- Jan 2011to Jan 2011
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects were selected based on the following inclusion criteria:
- Provide written informed consent.
- Must be healthy, adult, human beings between 18 and 45 years of age(both inclusive) weighing at least 50 kg.
- Having a body mass index between 18.5 and 24.9 (both inclusive),calculated as weight in Kg/height in m2
- Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study.(Laboratory values must be within normal limits or considered by the physician/investigator to be of no clinical significance).
- Female Subjects 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.
- surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
Who cannot join
- The subjects were excluded based on the following criteria during screening and during the study:
- Incapable of understanding the informed consent.
- Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg.
- Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.
- Oral temperature is below 95.0°F or above 98.6°F.
- Pulse rate below 50/min or above 100/min.
Show all 20Show fewer
- History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs.
- Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
- Consumption of grapefruit for the past ten days prior to the check-in, in each period.
- Habit of tobacco chewing.
- Habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period.
- Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period.
- Difficulty in abstaining from xanthine containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period.
- Intake of over the counter (OTC) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing.
- Clinically significant abnormalities and lor with significant diseases.
- Confirmed positive in alcohol screening.
- Confirmed positive in selected drug of abuse.
- Participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study.
- Confirmed positive in urine pregnancy test.
- Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study.
Trial locations and contacts
1 site in 1 country.
India1 site
Bioserve Clinical Research Private Limited
Hyderabad, Andhra Pradesh, 500 037
About this study
Official title: An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Oral Bioequivalence Study of Metoprolol Succinate Extended-Release Tablets 50 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of TOPROL-XL® (Containing Metoprolol Succinate) Extended-Release Tablets 50 mg of AstraZeneca LP Wilmington, DE in Healthy, Adult, Human Subjects Under Fasting Conditions
The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol Succinate Extended-Release Tablets 50 mg under fasting conditions
Read the detailed description
An open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, oral bioequivalence study of Metoprolol Succinate Extended-Release tablets 50 mg of Dr. Reddy's Laboratories Limited,under fasting conditions
- Conditions
- Healthy
- Being tested
- Metoprolol Succinate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoprolol SuccinateDrug
Also called TOPROL-XL®
| Study group | Role | What they receive |
|---|---|---|
| Metoprolol Succinate ER Tablets, 50 mg | Experimental | Metoprolol Succinate ER Tablets, 50 mg of Dr.Reddy's Laboratories Ltd Receives: Drug: Metoprolol Succinate |
| TOPROL-XL ER Tablets 50 mg | Active comparator | TOPROL-XL ER Tablets 50 mg of AstraZeneca Receives: Drug: Metoprolol Succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC)
Measured: Pre-dose (0.00) and 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 18.00, 20.00, 24.00, 36.00 and 48.00 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 posted27 Sep 2012 (estimated)
- Study startJan 2011
- Primary completionJan 2011
- Study completionJan 2011
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. P. Vijaya Lakshmi, Clinical Investigator, Principal investigator, Bioserve Clinical Research Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694797
- Sponsor's protocol ID
- 642/09
- Status last verified
- Nov 2010
- First submitted
- 24 Sep 2012
- Last updated
- 28 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Oral Bioequivalence Study of Metoprolol Succinate Extended-Release Tablets 50 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of TOPROL-XL® (Containing Metoprolol Succinate) Extended-Release Tablets 50 mg of AstraZeneca LP Wilmington, DE in Healthy, Adult, Human Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01694797
- Acronym / sponsor ID
- 642/09
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 27 Sep 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.
The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol Succinate Extended-Release Tablets 50 mg under fasting conditions
Detailed description
An open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, oral bioequivalence study of Metoprolol Succinate Extended-Release tablets 50 mg of Dr. Reddy's Laboratories Limited,under fasting conditions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metoprolol Succinate ER Tablets, 50 mg | Experimental | Drug: Metoprolol SuccinateMetoprolol Succinate ER Tablets, 50 mg of Dr.Reddy's Laboratories Ltd |
| TOPROL-XL ER Tablets 50 mg | Active comparator | Drug: Metoprolol SuccinateTOPROL-XL ER Tablets 50 mg of AstraZeneca |
Who may qualify
- Ages
- 18 to 45 years
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Provide written informed consent.
- Must be healthy, adult, human beings between 18 and 45 years of age(both inclusive) weighing at least 50 kg.
- Having a body mass index between 18.5 and 24.9 (both inclusive),calculated as weight in Kg/height in m2
- Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study.(Laboratory values must be within normal limits or considered by the physician/investigator to be of no clinical significance).
- Female Subjects 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.
Key exclusion criteria (20 listed)
- The subjects were excluded based on the following criteria during screening and during the study:
- Incapable of understanding the informed consent.
- Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg.
- Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.
- Oral temperature is below 95.0°F or above 98.6°F.
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 SuccinateAlso: TOPROL-XL® | Drug | Metoprolol Succinate ER Tablets, 50 mg, TOPROL-XL ER Tablets 50 mg |
Primary outcome
Area under curve (AUC)
Time frame: Pre-dose (0.00) and 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 18.00, 20.00, 24.00, 36.00 and 48.00 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 28 Sep 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. P. Vijaya Lakshmi, Clinical Investigator principal investigator
Bioserve Clinical Research Private 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 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 7 inclusion and 20 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 Sep 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: Pre-dose (0.00) and 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 18.00, 20.00, 24.00, 36.00 and 48.00 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 Sep 2012.