HealthyPhase 1NCT01167933
Bioequivalence Study of Simvastatin Tablets, 80 mg of Dr. Reddy's Under Fed Conditions
A Phase 1 study testing Simvastatin in people with Healthy, run by Dr. Reddy's Laboratories Limited.
Trial summary
The purpose of this study is to compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg tablets of MercK \& Co. Inc, USA in healthy subjects under fed conditions monitor adverse events and to ensure the safety of subjects. 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?
- Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Apr 2005
- 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 will provide written informed consent.
- Subjects must be healthy adults within 18-45 years of age (inclusive) weighing at least 50 kg.
- Subjects must be within ±10% of ideal body weight in relation to height according to Life Insurance Corporation of India height-weight chart for non-medical cases.
- Subjects must be of normal health as determined by medical history and physical examination performed within 15 days prior' to the commencement of the study.
- Have normal ECG, X-ray and vital signs.
- Availability of subject 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, or abstinence.
- is postmenopausal for at least 1 year.
- is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject) No female volunteers turned up to the site for participating in the study.
Who cannot join
- Bioequivalence studies are usually conducted in healthy adult subjects in order to assess and compare the pharmacokinetic profile of test and reference formulations under uniform conditions. Therefore it is essential to exclude those subjects who show abnormalities with respect to their health parameters. Subjects were excluded to participate in the study based on certain criteria. These criteria were made in order to safeguard the health of the subjects enrolled into the study.
- Subjects incapable of understanding the informed consent.
- Subjects with BP≤90/60 or BP≥140/90
- History of hypersensitivity or idiosyncratic reaction to Simvastatin.
- Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal, endocrine, immunologic, neurologic and haematologic function.
- Regular smoker who smokes more than ten cigarettes daily and has difficulty in abstaining from smoking for the duration of each study period.
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- Subjects who has taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication within the past 30 days prior to start of clinical period.
- 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 tested positive at screening for Human Immunodeficiency Virus, Hepatitis B Surface Antigen or Hepatitis C Virus
- Subjects with positive urine screen for drugs of abuse.
- Any subject in whom Simvastatin is contraindicated for medical reasons.
- Subjects who have used any drugs or substances such as herbal preparations known to be strong inhibitors of CYP.enzymes (formerly known as cytochrome P450 enzymes) within 14 days prior to the first dose.
- Female volunteers demonstrating a positive pregnancy screen.
- Female volunteers who are-currently breast-feeding. No female volunteers reported to study site for participating in the study.
About this study
Official title: A Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study of Simvastatin 80 mg Tablets of Dr. Reddy's to be Compared With Zocor® 80 mg Tablets of Merck & Co. Inc., USA in Healthy Adult Subjects Under Fed Conditions
The purpose of this study is to
- compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg tablets of MercK \& Co. Inc, USA in healthy subjects under fed conditions
- monitor adverse events and to ensure the safety of subjects.
Read the detailed description
A randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study of Simvastatin 80 mg tablets of Dr. Reddy's Laboratories Limited to be compared with Zocor® 80 mg tablets of Merck \& Co. Inc., USA in healthy, adult, human subjects under fed conditions.
- Conditions
- Healthy
- Being tested
- Simvastatin
- Keywords
- Bioequivalence, Crossover, Simvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Also called Zocor® 80 mg tabletsof Merck & Co. Inc., USA
Simvastatin 80 mg tablets Dr. Reddy's Laboratories Ltd
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Experimental | Simvastatin 80 mg tablets Dr. Reddy's Laboratories Ltd. Receives: Drug: Simvastatin |
| Zocor | Active comparator | Zocor® 80 mg tablets of Merck \& Co. Inc., USA Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax and AUC parameters
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJan 2005
- Primary completionApr 2005
- Study completionApr 2005
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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mangesh Kulkarni, Principal investigator, Vimta Labs Limited, Hyderabad, India, 500 051
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167933
- Sponsor's protocol ID
- 8340
- Status last verified
- Jul 2010
- First submitted
- 21 Jul 2010
- Last updated
- 9 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study of Simvastatin 80 mg Tablets of Dr. Reddy's to be Compared With Zocor® 80 mg Tablets of Merck & Co. Inc., USA in Healthy Adult Subjects Under Fed Conditions
- ClinicalTrials.gov ID
- NCT01167933
- Acronym / sponsor ID
- 8340
- Conditions
- Healthy
- Keywords
- Bioequivalence, Crossover, Simvastatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 22 Jul 2010 (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
- compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg tablets of MercK \& Co. Inc, USA in healthy subjects under fed conditions
- monitor adverse events and to ensure the safety of subjects.
Detailed description
A randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study of Simvastatin 80 mg tablets of Dr. Reddy's Laboratories Limited to be compared with Zocor® 80 mg tablets of Merck \& Co. Inc., USA in healthy, adult, human subjects under fed conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Experimental | Drug: SimvastatinSimvastatin 80 mg tablets Dr. Reddy's Laboratories Ltd. |
| Zocor | Active comparator | Drug: SimvastatinZocor® 80 mg tablets of Merck \& Co. Inc., USA |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subjects will provide written informed consent.
- Subjects must be healthy adults within 18-45 years of age (inclusive) weighing at least 50 kg.
- Subjects must be within ±10% of ideal body weight in relation to height according to Life Insurance Corporation of India height-weight chart for non-medical cases.
- Subjects must be of normal health as determined by medical history and physical examination performed within 15 days prior' to the commencement of the study.
- Have normal ECG, X-ray and vital signs.
Key exclusion criteria (17 listed)
- Bioequivalence studies are usually conducted in healthy adult subjects in order to assess and compare the pharmacokinetic profile of test and reference formulations under uniform conditions. Therefore it is essential to exclude those subjects who show abnormalities with respect to their health parameters. Subjects were excluded to participate in the study based on certain criteria. These criteria were made in order to safeguard the health of the subjects enrolled into the study.
- Subjects incapable of understanding the informed consent.
- Subjects with BP≤90/60 or BP≥140/90
- History of hypersensitivity or idiosyncratic reaction to Simvastatin.
- Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal, endocrine, immunologic, neurologic and haematologic function.
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 |
|---|---|---|
| SimvastatinAlso: Zocor® 80 mg tabletsof Merck & Co. Inc., USASimvastatin 80 mg tablets Dr. Reddy's Laboratories Ltd | Drug | Simvastatin, Zocor |
Primary outcome
Bioequivalence based on Cmax and AUC parameters
Time frame: 4 months
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 Aug 2010.
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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.
Mangesh Kulkarni principal investigator
Vimta Labs Limited, Hyderabad, India, 500 051
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Simvastatin in people with Healthy, run by Dr. Reddy's Laboratories Limited.
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 17 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 Aug 2010. 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 based on Cmax and AUC parameters (time frame: 4 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 9 Aug 2010.