Pharmacokinetic Characterization of Two Novel CG5503 Tablet Formulations in Healthy Volunteers

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study investigated the pharmacokinetics (how a drug is taken up and excreted from the body), safety, and tolerability of 2 new tapentadol (CG5503) tablet formulations compared to a previously characterized tapentadol prolonged-release (PR) tablet formulation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Grünenthal GmbH
• Treatments: Tapentadol

Criteria

Inclusion Criteria:

• Male Caucasian participants, aged 18-55 years;

• Body Mass Index between 18 and 30 kg/m2 inclusive;

• Participants must be in good health as determined by medical history, physical examination, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters;

• Participants giving written informed consent to participate within this study.

Exclusion Criteria:

• Resting pulse rate equal to or less than 45 or equal to or above 95 beats / min;

• Resting blood pressure: systolic blood pressure equal to or less than 100 and equal to or above 140 mmHg, diastolic blood pressure equal to or less than 50 and equal to or above 90 mmHg;

• Positive human immunodeficiency virus (HIV) type 1/2 antibodies, hepatitis B surface (HBs) antigen, hepatitis B core (HBc) antibodies, hepatitis C virus (HCV) antibodies;

• History or presence of orthostatic hypotension;

• Participation in another clinical study in the last three months before starting this study (exception: characterization of metabolizer status);

• Positive screening of drug abuse;

• Diseases or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs;

• Marked repolarization abnormality (e.g., suspicious or definite congenital long QT syndrome);

• Bronchial asthma;

• Definite or suspected history of drug allergy or hypersensitivity;

• Participants who have received any prescribed and non-prescribed systemic or topical medication two weeks before and during the study with the exception of short term medication, e.g. headache with paracetamol;

• Evidence of alcohol or drug abuse;

• Not able to abstain from drinking of caffeine containing beverages (tea, coffee, chocolate or cola),

• Consumption of any quinine containing beverages (bitter lemon, tonic water) or food within two weeks before and during the study;

• Drinking of alcohol containing beverages within 48 hours before administration of investigational product(s);

• Blood donation (above 100 mL) or comparable blood losses during the last 3 months;

• History of seizures or at risk (i.e. head trauma, epilepsy in family anamnesis, unclear loss of consciousness);

• Known or suspected of not being able to comply with the study protocol;

• Not able to communicate meaningfully with the investigator and staff;

• Smoking of more than 20 cigarettes/day.