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HealthyPhase 1NCT01146067

Bioequivalence Study of Rivastigmine 1.5 mg Capsules Under Fasting Conditions

A Phase 1 study testing Rivastigmine in people with Healthy, run by Dr. Reddy's Laboratories Limited.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a bioequivalence study of Rivastigmine 1.5 mg capsules and Exelon Administered as 1.5 mg capsule in Healthy subjects under fasting conditions. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Rivastigmine
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 2004to Feb 2004
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects enrolled in this study will be members of the community at large.
  • The recruitment advertisements may use various media types (e.g. radio, newspaper, Anapharm Web site, Anapharm volunteers' database). Subjects must meet all of the following criteria in order to be included in the study:
  • Male or female, smoker or non-smoker, 18 years of age and older.
  • Capable of consent.

Who cannot join

  • Subjects to whom any of the following applies will be excluded from the study:
  • Clinically significant illnesses within 4 weeks prior to the administration of the study medication.
  • Clinically significant surgery within 4 weeks prior to the administration of the study medication.
  • Any clinically significant abnormality found during medical screening.
  • Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
  • Abnormal laboratory tests judged clinically significant.
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  • Positive testing for hepatitis H, hepatitis C, or HN at screening.
  • BCG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
  • BMI2: 30.0.
  • History of significant alcohol abuse within six months prior to the screening visit or any indication of the regular use of more than fourteen units of alcohol per week (l Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).
  • History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
  • History of allergic reactions to rivastigmine or other related drugs.
  • History of allergic reactions to heparin.
  • Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine)within 30 days prior to administration of the study medication.
  • Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
  • Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
  • Any clinically significant history or presence of clinically significant neurological,endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
  • Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption or hormonal contraceptives.
  • Difficulty to swallow study medication.
  • Smoking more than 25 cigarettes per day.
  • Any food energy, intolerance, restriction or special diet that could, in the opinion of the Medical Sub-Investigator, contraindicate the subject's participation in this study.
  • A depot injection or an implant of any drug (other than hormonal contraceptive) within 3 months prior to administration of study medication.
  • Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:
  • 50 mL to 300 mL of whole blood within 30 days,
  • 300 mL to 500 mL of whole blood within 45 days, or
  • more than 500 mL of whole blood within 56 days prior to drug administration.
  • History of ulcer disease.
  • History of asthma or obstructive pulmonary disease.
  • Use of any nonsteroidal anti-inflammatory drugs (e.g. Motrin®, Advil®, within 14 days prior to drug administration.
  • History of seizures, urinary obstruction or benign prostatic hypertrophy.

About this study

Official title: Bioequivalence Study of Rivastigmine 1.5 mg Capsules (Test)of Dr.Reddy's Laboratories Limited Versus Exelon (Reference),Administered as 1 x 1.5 mg Capsule Under Fasting Conditions

This is a bioequivalence study of Rivastigmine 1.5 mg capsules and Exelon Administered as 1.5 mg capsule in Healthy subjects under fasting conditions.

Read the detailed description

Single center, bioequivalence, open-label, randomized, 2-way crossover study administered as 1 x 1.5 mg capsule in healthy subjects under fasting conditions.

Conditions
Healthy
Being tested
Rivastigmine
Keywords
Bioequivalence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RivastigmineDrug

    Also called Exelon 1.5 mg capsules

    Rivastigmine capsules 1.5 mg

Study groups in NCT01146067
Study groupRoleWhat they receive
RivastigmineExperimentalRivastigmine capsules 1.5 mg of Dr.Reddy's Laboratories Limited
Receives: Drug: Rivastigmine
ExelonActive comparatorExelon 1.5 mg capsules of Novartis
Receives: Drug: Rivastigmine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bioequivalence based on Cmax and AUC parameters

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2010 (estimated)
  2. Study startJan 2004
  3. Primary completionFeb 2004
  4. Study completionFeb 2004

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01146067
Sponsor's protocol ID
30496
Status last verified
Jun 2010
First submitted
10 Feb 2010
Last updated
13 Jan 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rivastigmine 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 4 inclusion and 30 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 13 Jan 2012. 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: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01146067.

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 13 Jan 2012.

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