Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

Epilepsy Clinical Trial

Official title:

Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01678976
• Other study ID #: BIA-2093-104
• Status: Completed
• Phase: Phase 1
• First received: August 31, 2012
• Last updated: December 19, 2014
• Start date: March 2002
• Est. completion date: April 2002

Study information

• Verified date: December 2014
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: National Pharmacy and Medicines Institute
• Study type: Interventional

Clinical Trial Summary

To investigate the pharmacokinetics of a single 900 mg oral dose of BIA 2-093 and a single 900 mg oral dose of Oxcarbazepine in healthy volunteers and to assess the tolerability of a single 900 mg dose of BIA 2-093 and Oxcarbazepine.

Description:

Single centre, open label, balanced randomised, two-way crossover study in 12 healthy volunteers. The study consisted of 2 periods separated by a washout period of 7 days or more. On each of the study periods the volunteers received either a single 900 mg oral dose of BIA 2-093 or a single 900 mg oral dose of Oxcarbazepine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2002
• Est. primary completion date: April 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Male or female subjects aged between 18 and 45 years, inclusive.

• Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.

• Subjects who were healthy as determined by pre-study medical history, physical examination, neurological examination, and 12-lead ECG.

• Subjects who had clinical laboratory tests acceptable.

• Subjects who were negative for HBs Ag, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening.

• Subjects who were negative for alcohol and drugs of abuse at screening and admission.

• Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.

• Subjects who were able and willing to give written informed consent.

• In case of female volunteers, subjects who were not of childbearing potential by reason of surgery or, if of childbearing potential, used one of the following methods of contraception: double-barrier, intrauterine device or abstinence.

• In case of female volunteers, subjects who had a negative pregnancy test at screening and admission

Exclusion Criteria:

• Subjects who did not conform to the above inclusion criteria.

• Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.

• Subjects who had a clinically relevant surgical history.

• Subjects who had a clinically relevant family history.

• Subjects who had a history of relevant atopy.

• Subjects who had a history of relevant drug hypersensitivity.

• Subjects who had a history of alcoholism or drug abuse.

• Subjects who consumed more than 21 units of alcohol a week.

• Subjects who had a significant infection or known inflammatory process on screening and/or admission.

• Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn).

• Subjects who had used prescription drugs within 4 weeks of first dosing.

• Subjects who had used over-the-counter medication excluding oral routine vitamins but including mega dose vitamin therapy within one week of first dosing.

• Subjects who had used any investigational drug and/or participated in any clinical trial within 2 months of their first admission.

• Subjects who had previously received BIA 2-093.

• Subjects who had donated and/or received any blood or blood products within the previous 2 months prior to screening.

• Subjects who were vegetarians, vegans and/or had medical dietary restrictions.

• Subjects who could not communicate reliably with the investigator.

• Subjects who were unlikely to co-operate with the requirements of the study.

• Subjects who were unwilling or unable to give written informed consent.

• In case of female volunteers, subjects who were pregnant or breast-feeding.

• In case of female volunteers, subjects who were of childbearing potential and did not use an approved effective contraceptive method or used oral contraceptives.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• BIA 2-093
Tablets containing BIA 2-093 in doses of 300 and 600 mg
• Oxcarbazepine
Tablets containing 300 mg and 600 mg of Trileptal®

Locations

Country	Name	City	State
Portugal	BIAL - Portela & Cª - Human Pharmacology Unit (UFH)	S. Mamede do Coronado	Trofa

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total of Subjects Reporting at Least One Adverse Event	Monitoring of Adverse Events throughout the study: Safety was evaluated from the number of reported adverse events (AEs) by patient	4 weeks	Yes
Primary	Maximum Drug Concentration (Cmax)	Maximum observed plasma concentration (Cmax) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.	at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose	No
Secondary	Area Under the Plasma Concentration Versus Time Curve (AUC)	Area under the plasma concentration versus time curve (AUC) to last measurable time point (AUC0-t) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.	at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose	No