FastingPhase 1NCT01372280
Galantamine Bioequivalence Study of Dr. Reddy's Under Fasting Condition
A Phase 1 study testing Reminyl in people with Fasting, run by Dr. Reddy's Laboratories Limited.
Trial summary
Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fasting condition. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- Reminyl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Nov 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 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:
- Healthy adult male volunteers, 18-55 years of age;
- Weighing at least 60 kg and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);
- Medically healthy subjects with clinically normal laboratory profiles. vital signs and ECGs;
- Give voluntary written informed consent to participate in the study.
Who cannot join
- Subject candidates must not be enrolled in the study if they meet any of the following criteria:
- 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 galantamine or other anticholinesterase inhibitors;
- asthma and seizures.
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- Subjects who tested positive at screening for HIV, HbsAg or HeV.
- Subjects whose PR interval is >200 msec at screening and prior to dosing.
- Subjects whose QTc interval is >450 msec at screening and prior to dosing.
- Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
- Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
- Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
- Subjects who, through completion of the study, would have donated in excess of:
- 500 mL of blood in 14 days; 1500 mL of blood in 180 days; 2500 ml of blood in 1 year.
- Subjects who have participated in another clinical trial within 28 days prior to the first dose.
About this study
Official title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr. Reddy's Laboratories, Ltd. and Janssen Pharmaceutical Products, l.P. (Reminyl®)4 mg Galantamine HBr Tablets in Healthy Adult Male Volunteers Under Fasting Conditions
Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fasting condition.
Read the detailed description
Comparative, Randomized, Single-Dose. 2-way Crossover Bioavailability Study of Dr.Reddy's laboratories, ltd. and Janssen Pharmaceutical Products. L.P. (Reminyte®)4 mg Galantamine HBr Tablets In Healthy Adult Male Volunteers under fasting Conditions
- Conditions
- Fasting
- Being tested
- Reminyl
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReminylDrug
Also called Reminyl 4 mg
Galantamine Hydrobromide Tablets 4 mg
| Study group | Role | What they receive |
|---|---|---|
| Galantamine | Experimental | Galantamine Hydrobromide Tablets of Dr. Reddy's Laboratories Limited Receives: Drug: Reminyl |
| Reminyl | Active comparator | Reminyl 4 mg tablets of Janssen Pharmaceutical Products Receives: Drug: Reminyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence 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.
- First posted13 Jun 2011 (estimated)
- Study startOct 2004
- Primary completionOct 2004
- Study completionNov 2004
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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gaerano Morelli, Principal investigator, Early Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372280
- Sponsor's protocol ID
- AA21896
- Status last verified
- Jan 2011
- First submitted
- 25 Jan 2011
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 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 Dr. Reddy's Laboratories, Ltd. and Janssen Pharmaceutical Products, l.P. (Reminyl®)4 mg Galantamine HBr Tablets in Healthy Adult Male Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01372280
- Acronym / sponsor ID
- AA21896
- Conditions
- Fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Oct 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 13 Jun 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.
Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fasting condition.
Detailed description
Comparative, Randomized, Single-Dose. 2-way Crossover Bioavailability Study of Dr.Reddy's laboratories, ltd. and Janssen Pharmaceutical Products. L.P. (Reminyte®)4 mg Galantamine HBr Tablets In Healthy Adult Male Volunteers under fasting Conditions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Galantamine | Experimental | Drug: ReminylGalantamine Hydrobromide Tablets of Dr. Reddy's Laboratories Limited |
| Reminyl | Active comparator | Drug: ReminylReminyl 4 mg tablets of Janssen Pharmaceutical Products |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:
- Healthy adult male volunteers, 18-55 years of age;
- Weighing at least 60 kg and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);
- Medically healthy subjects with clinically normal laboratory profiles. vital signs and ECGs;
- Give voluntary written informed consent to participate in the study.
Key exclusion criteria (15 listed)
- Subject candidates must not be enrolled in the study if they meet any of the following criteria:
- 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 galantamine or other anticholinesterase inhibitors;
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 |
|---|---|---|
| ReminylAlso: Reminyl 4 mgGalantamine Hydrobromide Tablets 4 mg | Drug | Galantamine, Reminyl |
Primary outcome
Bioequivalence on Cmax and AUC parameters
Time frame: 2 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 30 Jun 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.
Gaerano Morelli principal investigator
Early Clinical Research
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Reminyl in people with Fasting, 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 5 inclusion and 15 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 30 Jun 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 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?
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 30 Jun 2011.