DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Effects of TPV/r on the Pharmacokinetics of Carbamazepine in Healthy Adult Volunteers

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Carbamazepine (Drug); Tipranavir (Drug); Ritonavir (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

Summary

Study to assess the steady-state pharmacokinetics of carbamazepine (CBZ) at 200 mg or 100 mg twice daily, depending on tolerability, and administered alone and in combination with tipranavir/ritonavir (TPV/r) after a single dose (500/200 mg) and at steady-state (500/200 mg twice-daily)

Clinical Details

Official title: A Single Centre, Open-label Study With Healthy Adult Volunteers to Determine the Effects of Single-dose and Steady-state TPV/r 500/200 mg on the Steady-state Pharmacokinetics of Carbamazepine (200 mg Twice Daily)

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Area under the concentration-time curve of Carbamazepine in plasma over the time interval t0h to t12h (AUC0-12h)

Maximum measured concentration of Carbamazepine in plasma (Cmax)

Drug concentration of Carbamazepine in plasma at 12 hours after drug administration (Cp12h)

Secondary outcome:

AUC0-12h

Cmax

Cp12h

Clearance (CL/F)

Volume of distribution

Time from dosing to the maximum concentration (Tmax)

t1/2 (terminal elimination half-life)

Number of subjects with adverse events

Number of subjects with clinically relevant changes in laboratory parameters

Eligibility

Minimum age: 20 Years. Maximum age: 58 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy male and non-pregnant, non-lactating female subjects as determined by results

of screening

- Signed written informed consent in accordance with Good Clinical Practice (GCP) and

local legislation

- The ability to understand and sign a written informed consent form, prior to

participation in any screening procedures and must be willing to comply with all study requirements

- Age >19 and <59 years

- Weight ≥ 60 kg

- BMI >18. 5 and <35 kg/m2

- Ability to maintain adequate contraception if applicable

Exclusion Criteria:

- Any finding of the medical examination (including blood pressure, pulse rate, and

electrocardiogram) deviating from normal and of clinical relevance

- AV block including 1°

- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,

immunologic, haematological, oncological or hormonal disorders

- Surgery of gastrointestinal tract (except appendectomy)

- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or

neurological disorders

- Relevant history of orthostatic hypotension, fainting spells or blackouts

- Chronic or relevant acute infections

- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant

to the trial as judged by the investigator

- Known hypersensitivity to TPV, Ritonavir (RTV), carbamazepine or antiretroviral drugs

(marketed or experimental use as part of clinical research studies)

- Known elevated liver enzymes in past trials with any compound

- Intake of drugs with a long half-life (>24 hours) (<1 month prior to administration

or during the trial)

- Prescription or over the counter medications (including vitamins, minerals, herbal

supplements and antacids), dietary supplements 14 days prior to study drug administration or expected during the trial)

- Participation in another trial with an investigational drug (<2 months prior to

administration or expected during trial)

- Smoker with a consumption of >10 cigarettes or >3 cigars or >3 pipes/day and those

who cannot keep tobacco intake constant

- Alcohol abuse (>60 g/day)

- Drug abuse

- Blood donation or loss >400 mL, <1 month prior to administration or expected during

the trial

- Clinically relevant laboratory abnormalities

- Inability to comply with dietary regimen of study centre

For female subjects:

- Pregnancy or planning to become pregnant within 60 days of study completion

- Positive pregnancy test

- Have not been using a barrier method of contraception for at least 3 months prior to

participation in the study

- Are not willing or are unable to use a reliable method of barrier contraception (such

as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and up to 2 months after completion/termination of the trial

- Chronic use of oral contraception or hormone replacement containing ethinyl estradiol

- Breast-feeding

Locations and Contacts

Additional Information

Starting date: November 2005
Last updated: September 30, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017