Last updated: 11/03/2018 18:57:54
Topiramate Bioequivalence Study Brazil - Fast
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A relative bioavailability study of two formulations of topiramate 100 mg coated tablet in healthy male volunteers, the test formulation produced by Dr. Reddy's Laboratories Ltd. and the reference formulation (Topamax®) marked by Janssen-Cilag Farmacêutica Ltda.
Trial description: This study is prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods. The volunteers received, in each period, the reference or the test formulation, according to the randomization list, under fasting conditions, in order to evaluate if the reference and test formulations are bioequivalent.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Area under curve of plasma concentration of drug from time 0 (zero) from time t (last measurable concentration)
Timeframe: Collection points from time 0 to 192 hours evaluated in two periods
Maximum observed concentration of drug through time (Cmax)
Timeframe: Collection points from time 0 to 192 hours evaluated in two periods
Area under curve of plasma concentration of drug from the time 0 (zero) extrapolated to infinity (AUC0-inf)
Timeframe: Collection points from time 0 to 192 hours evaluated in two periods
Time of maximum observed concentration (Tmax)
Timeframe: Collection points from time 0 to 192 hours evaluated in two periods
Terminal half-life - T1/2
Timeframe: Collection points from time 0 to 192 hours evaluated in two periods
First order rate constant associated with the terminal portion of the curve (Kel)
Timeframe: Collection points from time 0 to 192 hours evaluated in two periods
Secondary outcomes:
Not applicable
Interventions:
Drug: Topiramate coated tablet
Drug: Topamax® coated tablet
Enrollment:
26
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Epilepsy, Tonic-Clonic
Product
topiramate
Collaborators
Not applicable
Study date(s)
July 2011 to September 2011
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
- Male
- Age between 18 and 50 years
- The volunteer has a known hypersensitivity to the study drug (topiramate) or to compounds chemically related
- History or presence of hepatic or gastrointestinal illnesses, or other condition that interferes over the drug’s absorption, distribution, excretion or metabolism
Inclusion and exclusion criteria
Inclusion criteria:
- Male
- Age between 18 and 50 years
- Body mass index between 19 and 28,5 kg/m2
- Good health conditions
- Capable to understand the study's nature and aim, including risks and adverse effects and with intention to cooperate with the researcher and to act in compliance with requirements of the assay, this will be confirmed by the informed consent's signature
Exclusion criteria:
- The volunteer has a known hypersensitivity to the study drug (topiramate) or to compounds chemically related
- History or presence of hepatic or gastrointestinal illnesses, or other condition that interferes over the drug’s absorption, distribution, excretion or metabolism
- History of hepatic, renal, pulmonary, gastrointestinal, epileptic, hematologic or psychiatric illness; hypo or hypertension of any etiologic that needs pharmacologic treatment; has history or had myocardial infarction, angina and/or heart insufficiency
- Non-recommended electrocardiographic findings, according to investigator criteria, for the study’s participation
- The results of the laboratory exams are out of the values considered as normal according to this protocol’s rules, unless that they are considered as clinically irrelevant by the investigator
- The volunteer is a smoker
- The volunteer ingests more than 5 cups of coffee or tea a day
- Has history of alcohol or drugs abuse
- Use any regular drug within the 02 weeks that preceded the beginning of the treatment and the assessment date, or employed any drug that can interfere with the study within one week
- The volunteer was hospitalized for any reason within 08 weeks of the beginning of this study’s first period of treatment and the assessment date
- Treatment within the 03 previous months of the study with any known drug that presents toxic potential for important organs
- The volunteer participated in any experimental study or ingested any experimental drug within the 06 months that precede the beginning of this study and the assessment date
- The volunteer donated or lost 450 mL or more of blood within the 03 months that preceded to the study initiation or donated more than 1500 mL within 12 months between the beginning of the study and the assessment date
- Consume of inductive drugs and/or enzymatic inhibitors (CYP450
- hepatic), that are toxic for the organism or presenting long half-life’s elimination within the 04 weeks that precede the study’s initiation
- Consume of alcohol in 48 hours antecedents to the admission to the study and along the study period
- Consume of food or beverages containing grapefruit (grapefruit) within 24 hours preceding each study period
- History of serious adverse reactions or hypersensitivity to any drug
- The volunteer has any condition that obstructs his participation in the study according the investigator’s judgement
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2011-11-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 116144 can be found on the GSK Clinical Study Register.
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