HealthyNCT00901784
Bioequivalence Study of Topiramate Tablets 25mg Under Fasting Conditions
A study testing Topiramate in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in Canada.
Trial summary
The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Ortho-McNeil Pharmaceutical (Topamax®) 25 mg topiramate tablets following a 50 mg dose under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Topiramate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2001to Oct 2001
- Phase
- Interventional
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- This study involved healthy adult male volunteers, 18-45 years of age, weighing at least 52 kg, who are within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).
- Only medically healthy subjects with clinically normal laboratory profiles were enrolled 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:
- Hypersensitivity or idiosyncratic reaction to topiramate
- Nephrolithiasis or gout
- Alcoholism or drug abuse within the past year
Show all 18Show fewer
- Subjects who had been on an abnormal diet (for whatever reason) during the 28 days preceding the study.
- Subjects who had any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days of study start.
- Subjects who had used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days of study start.
- Subjects who, through completion of the study, would have donated in excess of:
- 500 mL of blood in 14 days, or
- 500-750 mL of blood in 14 days (unless approved by the Principal Investigator),
- 1000 mL of blood in 90 days,
- 1250 mL of blood in 120 days,
- 1500 mL of blood in 180 days,
- 2000 mL of blood in 270 days,
- 2500 mL of blood in 1 year,
- Subjects who had participated in another clinical trial within 28 days of study start.
Trial locations and contacts
1 site in 1 country.
Canada1 site
MDS Pharina Services (Clinical Research Center)
Saint Laurent, Québec, H4R 2N6
About this study
Official title: Comparative, Randomized, Single Dose, 2-Way Crossover Relative Bioavailability Study of Ranbaxy and Ortho-McNeil Pharmaceutical (Topamax®) 25 mg Topiramate Tablets Following a 50 mg Dose in Healthy Adult Males Under Fasting Conditions
The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Ortho-McNeil Pharmaceutical (Topamax®) 25 mg topiramate tablets following a 50 mg dose under fasting conditions.
Read the detailed description
This was an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult male volunteers and 4 alternates. All 28 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 24-hour blood draw. Subjects were to return for the 48-, 72-, 96- and 120-hour blood draws. Both periods were separated by a washout period of 14 days.
- Conditions
- Healthy
- Being tested
- Topiramate
- Keywords
- Topiramate fasting study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
25mg Tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 25 mg Topiramate tablets of Ranbaxy Laboratories, Ltd Receives: Drug: Topiramate |
| 2 | Active comparator | (Topamax®) 25 mg Topiramate tablets of Ortho-McNeil Pharmaceutical, Inc. New jersey 08869 Receives: Drug: Topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence evaluation of Topiramate 25mg tablets
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startSep 2001
- Primary completionSep 2001
- Study completionOct 2001
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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901784
- Sponsor's protocol ID
- 011972
- Status last verified
- May 2009
- First submitted
- 13 May 2009
- Last updated
- 18 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Randomized, Single Dose, 2-Way Crossover Relative Bioavailability Study of Ranbaxy and Ortho-McNeil Pharmaceutical (Topamax®) 25 mg Topiramate Tablets Following a 50 mg Dose in Healthy Adult Males Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00901784
- Acronym / sponsor ID
- 011972
- Conditions
- Healthy
- Keywords
- Topiramate fasting study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Primary completion
- Sep 2001 (actual)
- Study completion
- Oct 2001 (actual)
- First posted
- 14 May 2009 (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 objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Ortho-McNeil Pharmaceutical (Topamax®) 25 mg topiramate tablets following a 50 mg dose under fasting conditions.
Detailed description
This was an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult male volunteers and 4 alternates. All 28 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 24-hour blood draw. Subjects were to return for the 48-, 72-, 96- and 120-hour blood draws. Both periods were separated by a washout period of 14 days.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Topiramate25 mg Topiramate tablets of Ranbaxy Laboratories, Ltd |
| 2 | Active comparator | Drug: Topiramate(Topamax®) 25 mg Topiramate tablets of Ortho-McNeil Pharmaceutical, Inc. New jersey 08869 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- This study involved healthy adult male volunteers, 18-45 years of age, weighing at least 52 kg, who are within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).
- Only medically healthy subjects with clinically normal laboratory profiles were enrolled in the study.
Key exclusion criteria (18 listed)
- History or presence of significant:
- Subjects who had been on an abnormal diet (for whatever reason) during the 28 days preceding the study.
- Subjects who had any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days of study start.
- Subjects who had used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days of study start.
- Subjects who, through completion of the study, would have donated in excess of:
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 |
|---|---|---|
| Topiramate25mg Tablets | Drug | 1, 2 |
Primary outcome
Bioequivalence evaluation of Topiramate 25mg tablets
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 18 Jun 2009.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topiramate in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in Canada.
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 2 inclusion and 18 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 18 Jun 2009. 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 Canada. 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.
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 evaluation of Topiramate 25mg tablets. 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 18 Jun 2009.