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CompletedNCT00939692Updated Jul 16, 2013Results posted

Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fasted Conditions

A Phase 1 interventional study of Topiramate in Healthy, sponsored by Torrent Pharmaceuticals Limited. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-16.

Sponsored by Torrent Pharmaceuticals Limited · Phase 1, Interventional, and Screening

Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

  • Objective:

    • Compare the bioequivalence of a test topiramate formulation (Torrent Pharmaceuticals Limited) to an equivalent oral dose of the commercially available topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test population of 26 adult subjects under fasted conditions.

  • Clinical Design:

    • Studies were Randomized, Two-Way Crossover, Single-Dose,Open-Label in healthy human adult subjects.
02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Torrent Pharmaceuticals Limited is the lead sponsor of 71 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Sex: Male or Female; similar proportions of each preferred.
  • Age: At least 18 - 55 years (inclusive).
  • Weight: BMI (Body Mass Index) 19 kg/m2 - 30 kg/m2 (inclusive).

  • Qualifying subjects must be in good health and physical condition as determined by medical history, complete physical examination, and laboratory tests, all obtained within four (4) weeks prior to study start. The subject may not have a history of significant past illness expected to affect the investigation. The normal status of subjects will be confirmed by the following procedures:

    • Laboratory Tests: Serum pregnancy test (female subjects only), hemoglobin, hematocrit, RBC, WBC, platelet count, differential count, serum electrolytes (Na, K, Cl), fasting blood glucose, BUN, bilirubin, creatinine, AST, ALT, LD, alkaline phosphatase, urinalysis, drugs of abuse, HIV, Hepatitis B, and Hepatitis C will be done for screening purposes.
    • Laboratory values which are greater than 20% of the normal range will not qualify unless specifically accepted by a physician who is an investigator or sub-investigator for the clinical trial. Results of a serum pregnancy test (female subjects only), HIV, Hepatitis B, Hepatitis C, and drugs of abuse must be negative or non-reactive for the subject to qualify for the study.
    • Electrocardiogram: A 12-lead electrocardiogram (ECG) will be obtained for all subjects. The original tracings, plus interpretation, will be included in the case report form packet.
  • Subjects must read and sign the Consent Form.

Exclusion criteria

Exclusion Criteria:

  • Subjects not complying with the above inclusion criteria must be excluded from the study.

  • In addition, any one (1) of the conditions listed below will exclude a subject from the study:

    • History of treatment for alcoholism, substance abuse, or drug abuse within the past 24 months.
    • History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
    • History of GERD (gastroesophageal reflux disease), malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease.
    • History of treatment for asthma within the past five (5) years.
    • History of predisposition to renal calculi.
    • History of surgery within the past eight (8) weeks.
    • History of application of tattoo(s) within the past 30 days.
    • History of body piercing(s) within the past 30 days.
    • Females who are pregnant or lactating.
    • History of hypersensitivity to topiramate or any anticonvulsant medication.

  • Conditions upon screening which might contraindicate or require that caution be used in the administration of topiramate, including:

    • Sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm Hg.
    • Heart rate less than 50 beats per minute after a 5-minute rest in a seated position.
  • Inability to read and/or sign the consent form.
  • Treatment with any other investigational drug during the 30 days prior to the initial dosing for this study.
  • Subjects who have donated blood within 30 days prior to the initial dosing for this study.
  • Subjects who smoke more than 10 cigarettes per day.
  • Subjects who do not tolerate venipuncture.
  • Subjects who have difficulty fasting or consuming standardized meals.
05

Study design

Phase
Phase 1
Primary purpose
Screening
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Torrent Topiramate

    tablet containing 25 mg of topiramate (Torrent Pharmaceuticals)

    Drug: Topiramate

  • Active comparator
    Topamax

    tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)

    Drug: Topiramate

Interventions

  • DrugTopiramate

    Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug. IUPAC name 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate

06

What researchers measure

Primary outcomes

  1. Maximum Plasma Concentration (Cmax)

    The maximum or peak concentration that the drug reaches in the plasma

    Time frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.

  2. Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]

    The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)

    Time frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.

  3. The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)

    The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.

    Time frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.

07

Results

Posted Jul 16, 2013

Participant flow

Period 1 - First Intervention - 5 Days
Participant flow — Period 1 - First Intervention - 5 Days
MilestoneTorrent's Topiramate First, Then TopamaxTopamax First, Then Torrent's Topiramate
Started1313
Completed1213
Not completed10
Withdrew: Withdrawal by subject10
Period 2 - Second Intervent - 5 Days
Participant flow — Period 2 - Second Intervent - 5 Days
MilestoneTorrent's Topiramate First, Then TopamaxTopamax First, Then Torrent's Topiramate
Started1213
Completed1212
Not completed01
Withdrew: Protocol violation01

Outcome measures

PrimaryMaximum Plasma Concentration (Cmax)

The maximum or peak concentration that the drug reaches in the plasma

Time frame:
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.
Reported as:
Mean · ng/ml
Maximum Plasma Concentration (Cmax)
ng/mlTorrent's TopiramateTopamax
Maximum Plasma Concentration (Cmax)265.96 ± 105.09260.04 ± 85.05
PrimaryArea Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]

The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)

Time frame:
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.
Reported as:
Mean · mcg*hr/mL
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
mcg*hr/mLTorrent's TopiramateTopamax
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]1.51 ± 0.941.25 ± 0.79
PrimaryThe Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)

The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.

Time frame:
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.
Reported as:
Mean · ng·h/mL
The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)
ng·h/mLTorrent's TopiramateTopamax
The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)17796.46 ± 3500.7017770.47 ± 3944.14

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Torrent's Topiramate—0/26 (0%)2/26 (7.7%)
Topamax—0/26 (0%)1/26 (3.8%)
Most frequent other events
Most frequent other events
EventTorrent's TopiramateTopamax
DizzinessGeneral disorders1/261/26
PainGeneral disorders1/260/26
nauseaGeneral disorders0/261/26

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Torrent's TopiramateTopamaxTotal
<=18 years000
Between 18 and 65 years131326
>=65 years000
Age Continuous
Age Continuous(years)Torrent's TopiramateTopamaxTotal
Mean30.3 ± 10.930.3 ± 10.930.3 ± 10.9
Sex: Female, Male
Sex: Female, Male(Participants)Torrent's TopiramateTopamaxTotal
Female6612
Male7714
Region of Enrollment
Region of Enrollment(participants)Torrent's TopiramateTopamaxTotal
United States131326
08

Study locations

1 site
  • Gateway Medical Research, Inc.
    St, Charles, Missouri 63301, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00939692
Lead sponsor
Torrent Pharmaceuticals Limited
Responsible party
Sponsor
First posted
Jul 15, 2009
Start date
Jan 2007
Primary completion
Mar 2007
Completion
Apr 2007
Results posted
Jul 16, 2013
Last update
Jul 16, 2013
View the source record on ClinicalTrials.gov ↗

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