Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers | RxWiki

Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers

Overview[ - collapse ][ - ]

Purpose	The primary objective was to investigate whether multiple-dose administration of eslicarbazepine acetate affects the pharmacokinetics of metformin.
Condition	Neuropathic Pain
Intervention	Drug: Metformin + eslicarbazepine
Phase	Phase 1
Sponsor	Bial - Portela C S.A.
Responsible Party	Bial - Portela C S.A.
ClinicalTrials.gov Identifier	NCT00971295
First Received	September 2, 2009
Last Updated	June 18, 2012
Last verified	June 2012

Tracking Information[ + expand ][ + ]

First Received Date	September 2, 2009
Last Updated Date	June 18, 2012
Start Date	October 2007
Estimated Primary Completion Date	September 2008
Current Primary Outcome Measures	To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) affects the pharmacokinetics of metformin [Time Frame: 3 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures	To investigate the tolerability of concomitant administration of ESL and metformin [Time Frame: 3 weeks] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers
Official Title	Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers
Brief Summary	The primary objective was to investigate whether multiple-dose administration of eslicarbazepine acetate affects the pharmacokinetics of metformin.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Neuropathic Pain
Intervention	Drug: Metformin + eslicarbazepine 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days Other Names: Glucophage Zebinix Exalief
Study Arm (s)	Experimental: Metformin + ESL Metformin HCl 850 mg, ESL 1200 mg

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	20
Estimated Completion Date	September 2008
Estimated Primary Completion Date	December 2007
Eligibility Criteria	Inclusion Criteria: - Male or female subjects aged between 18 and 45 years, inclusive. - Body mass index (BMI) between 19 and 30 kg/m2, inclusive. - Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG. - Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening - Clinical laboratory test results clinically acceptable at screening and admission to each treatment period. - Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period. - Non-smokers or who smoke ≤ 10 cigarettes or equivalent per day. - Able and willing to give written informed consent. - (If female) Not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine device. - (If female) Negative urine pregnancy test at screening and admission to each treatment period. Exclusion Criteria: - Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders. - Clinically relevant surgical history. - History of relevant atopy or drug hypersensitivity. - History of alcoholism or drug abuse. - Consumed more than 14 units of alcohol a week. - Significant infection or known inflammatory process at screening or admission to each treatment period. - Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period. - Used medicines within 2 weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion. - Used any investigational drug or participated in any clinical trial within 6 months prior to screening. - Participated in more than 2 clinical trials within the 12 months prior to screening. - Donated or received any blood or blood products within the 3 months prior to screening. - Vegetarians, vegans or with medical dietary restrictions. - Could not communicate reliably with the investigator. - Unlikely to co-operate with the requirements of the study. - Unwilling or unable to give written informed consent. - (If female) Pregnant or breast-feeding. - (If female) Of childbearing potential and she did not use an approved effective contraceptive method (double-barrier or intra-uterine device) or she used oral contraceptives.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Portugal

Administrative Information[ + expand ][ + ]

NCT Number	NCT00971295
Other Study ID Numbers	BIA-2093-125
Has Data Monitoring Committee	No
Information Provided By	Bial - Portela C S.A.
Study Sponsor	Bial - Portela C S.A.
Collaborators	Not Provided
Investigators	Principal Investigator: Manuel Vaz-da-Silva, MD, PhD BIAL - Portela & Ca, S.A
Verification Date	June 2012

Locations[ + expand ][ + ]