Depression Clinical Trial
— GINGEROfficial title:
The Influence of GINkGo Biloba on the Pharmacokinetics of the UGT Substrate raltEgraviR (GINGER)
Verified date | November 2020 |
Source | Radboud University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to evaluate the effect of ginkgo biloba (steady state) on the pharmacokinetics of a single dose of the UGT-substrate raltegravir. Furthermore the safety profile of the combination is studied.
Status | Completed |
Enrollment | 18 |
Est. completion date | May 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Subject is at least 18 and not older than 55 years at screening. - Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to the first dosing - Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included. - Subject is able and willing to sign the Informed Consent Form prior to screening evaluations. - Subject is in good age-appropriate health condition as established by medical history, physical examination, electrocardiography, results of biochemistry, haematology and urinalysis testing within 4 weeks prior to Day 1. Results of biochemistry, haematology and urinalysis testing should be within the laboratory's reference ranges. If laboratory results are not within the reference ranges, the subject is included on condition that the Investigator judges that the deviations are not clinically relevant. This should be clearly recorded. - Subject has a normal blood pressure and pulse rate, according to the Investigator's judgement. Exclusion Criteria: - Documented history of sensitivity/idiosyncrasy to medicinal products or excipients. - Positive HIV test. - Positive hepatitis B or C test. - Pregnant female (as confirmed by an HCG test performed less than 4 weeks before Day 1) or breast-feeding female. Female subjects of childbearing potential without adequate contraception, e.g. hysterectomy, bilateral tubal ligation, (non-hormonal) intrauterine device, total abstinence, double barrier methods, or two years post-menopausal. They must agree to take precautions in order to prevent a pregnancy throughout the entire conduct of the trial. - Therapy with any drug (for two weeks preceding dosing), except for paracetamol. - Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular disorders, neurological disorders (especially seizures and migraine), psychiatric disorders, gastro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders. - Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. - History of or current abuse of drugs, alcohol or solvents. - Inability to understand the nature and extent of the trial and the procedures required. - Participation in a drug trial within 60 days prior to Day 1. - Donation of blood within 60 days prior to Day 1. - Febrile illness within 3 days before Day 1. |
Country | Name | City | State |
---|---|---|---|
Netherlands | CRCN, Radboud University Medical Centre | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Radboud University | Merck Sharp & Dohme Corp. |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | raltegravir concentrations | To determine the effect of chronic use of ginkgo biloba on the single-dose pharma-cokinetics (AUC0-inf, AUC0-12, Cmax, C12) of raltegravir 400mg in healthy volunteers. | pharmacokinetic curve after a single dose of raltegravir alone or added to steady state ginkgo biloba | |
Secondary | adverse events | To determine the safety of a single dose of raltegravir 400mg when combined with chronic use of ginkgo biloba. | during entire study |
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