HealthyPhase 1NCT01467687
Comparative Bioavailability Study of Synerx and Verelan PM 300 mg Verapamil HCl ER Capsules Under Fed Conditions
A Phase 1 study of Healthy, run by Synerx Pharma, LLC.
Trial summary
The purpose of this study is to determine the bioequivalency of Synerx Pharma Verapamil extended release capsules. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Aug 2007
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male or female volunteers, 18-55 years of age. Subjects will be continuous non-smokers for at least 3 months prior to the first dose.
- Weighing at least 60 kg for males and 52 kg for females and within the normal range according to accepted normal values of the Body Mass Index Chart (18.00 -28.00 kg/m2).
- Medically healthy subjects with clinically normal laboratory profiles, vital signs and ECGs.
- Absence of any exclusion criteria during history, physical, or laboratory evaluation.
- Confirmation that all female subjects are not pregnant by a certified, validated pregnancy test.
- Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be an acceptable birth control method Postmenopausal women with amenorrhea for at least 2 years will be eligible. Give voluntary written informed consent to participate in the study.
Who cannot join
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- In addition, history or presence of: alcoholism or drug abuse within the past year; hypersensitivity or idiosyncratic reaction to verapamil, other calcium ion influx inhibitors or any other component of the product formulations; idiosyncratic reaction to acetaminophen; malabsorption within the past year; recurrent headaches or migraines. Presence of a medical condition requiring regular treatment with prescription drugs.
- Tests giving reasonable suspicion of a disease that would contraindicate taking an investigational drug or that might affect the interpretation of the results of the study.
- Female subjects who are pregnant or lactating. Subjects who tested positive at screening for HIV, HbsAg or HCV. Positive test results for drugs of abuse or alcohol. Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or 100/55 mmHg prior to dosing in each period.
- Subjects whose pulse is lower than 55 b.p.m. at screening or 50 b.p.m. prior to dosing in each period.
- Subjects whose PR interval is >190 msec at screening and >200 msec prior to dosing in each period.
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- Subjects whose QTc interval is >450 msec at screening and prior to dosing in each period.
- Subjects who have used any drugs or substances known to be strong inducers and/or inhibitors of CYP enzymes within 28 days prior to the first dose.
- Subjects who have been on a special diet during the 28 days prior to the first dose and throughout the study.
- Subjects who donated 50 to 499 mL of blood within 30 days and more than 499 mL within 56 days prior to the first dose.
About this study
Official title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Synerx Pharma and Verelan PM 300 mg Verapamil HCl Extended Release Capsules Controlled-Onset in Healthy Aduly Volunteers Under Fed Conditions
The purpose of this study is to determine the bioequivalency of Synerx Pharma Verapamil extended release capsules.
Read the detailed description
The purpose of this study is to determine if Synerx Pharma Verapamil HCl ER Capsules are bioequivalent to Verelan PM capsules in healthy volunteers under food effect conditions.
- Conditions
- Healthy
- Being tested
- verapamil controlled release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
verapamil controlled releaseDrug
Also called Verelan PM, verapamil controlled release capsule
verapamil 300 mg controlled release capsule as a single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 300 mg capsule of Verelan PM or 300 mg verapamil controlled release capsule given orally with food as a single dose with blood collected at 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24, 30, 36, 48, 60 and 72 hours. Receives: Drug: verapamil controlled release |
| 2 | Active comparator | 300 mg capsule of Verelan PM or 300 mg verapamil controlled release capsule given orally with food as a single dose with blood collected at 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24, 30, 36, 48, 60 and 72 hours. Receives: Drug: verapamil controlled release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Statistical comparison of verapamil blood levels obtained over 72 hours when dosed with either the Verelan PM capsule or Synerx Pharma verapamil controlled release capsule. The comparison will compare Cmax and AUC and provide 80 to 125% confidence intervals for the values.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startJul 2007
- Primary completionAug 2007
- Study completionAug 2007
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synerx Pharma, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gaetano Morelli, MD, Principal investigator, MDS Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467687
- Sponsor's protocol ID
- AA32724
- Status last verified
- Nov 2011
- First submitted
- 31 Oct 2011
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Synerx Pharma and Verelan PM 300 mg Verapamil HCl Extended Release Capsules Controlled-Onset in Healthy Aduly Volunteers Under Fed Conditions
- ClinicalTrials.gov ID
- NCT01467687
- Acronym / sponsor ID
- AA32724
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Synerx Pharma, LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 9 Nov 2011 (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 determine the bioequivalency of Synerx Pharma Verapamil extended release capsules.
Detailed description
The purpose of this study is to determine if Synerx Pharma Verapamil HCl ER Capsules are bioequivalent to Verelan PM capsules in healthy volunteers under food effect conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: verapamil controlled release300 mg capsule of Verelan PM or 300 mg verapamil controlled release capsule given orally with food as a single dose with blood collected at 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24, 30, 36, 48, 60 and 72 hours. |
| 2 | Active comparator | Drug: verapamil controlled release300 mg capsule of Verelan PM or 300 mg verapamil controlled release capsule given orally with food as a single dose with blood collected at 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24, 30, 36, 48, 60 and 72 hours. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adult male or female volunteers, 18-55 years of age. Subjects will be continuous non-smokers for at least 3 months prior to the first dose.
- Weighing at least 60 kg for males and 52 kg for females and within the normal range according to accepted normal values of the Body Mass Index Chart (18.00 -28.00 kg/m2).
- Medically healthy subjects with clinically normal laboratory profiles, vital signs and ECGs.
- Absence of any exclusion criteria during history, physical, or laboratory evaluation.
- Confirmation that all female subjects are not pregnant by a certified, validated pregnancy test.
Key exclusion criteria (10 listed)
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- In addition, history or presence of: alcoholism or drug abuse within the past year; hypersensitivity or idiosyncratic reaction to verapamil, other calcium ion influx inhibitors or any other component of the product formulations; idiosyncratic reaction to acetaminophen; malabsorption within the past year; recurrent headaches or migraines. Presence of a medical condition requiring regular treatment with prescription drugs.
- Tests giving reasonable suspicion of a disease that would contraindicate taking an investigational drug or that might affect the interpretation of the results of the study.
- Female subjects who are pregnant or lactating. Subjects who tested positive at screening for HIV, HbsAg or HCV. Positive test results for drugs of abuse or alcohol. Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or 100/55 mmHg prior to dosing in each period.
- Subjects whose pulse is lower than 55 b.p.m. at screening or 50 b.p.m. prior to dosing in each 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 |
|---|---|---|
| verapamil controlled releaseAlso: Verelan PM, verapamil controlled release capsuleverapamil 300 mg controlled release capsule as a single dose | Drug | 1, 2 |
Primary outcome
Bioequivalence
Time frame: 72 hours
Statistical comparison of verapamil blood levels obtained over 72 hours when dosed with either the Verelan PM capsule or Synerx Pharma verapamil controlled release capsule. The comparison will compare Cmax and AUC and provide 80 to 125% confidence intervals for the values.
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 9 Nov 2011.
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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.
Gaetano Morelli, MD principal investigator
MDS Pharma
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Healthy, run by Synerx Pharma, LLC.
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 6 inclusion and 10 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 9 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: 72 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 9 Nov 2011; AzTrials last refreshed its copy on 6 Nov 2026.