Drug Interaction Clinical Trial
Official title:
An Open Label, Randomized, Single-dose, Fixed-Sequence Crossover Drug Interaction Study of Loperamide HCL With Grapefruit Juice
A 10-day study to determine if grapefruit juice has any effect on how loperamide (Imodium) affects the body and how the body affects loperamide.
Status | Completed |
Enrollment | 33 |
Est. completion date | November 2008 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 59 Years |
Eligibility |
Inclusion Criteria: - Healthy male and/or female subjects between the ages of 18 and 59 years, inclusive - No clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, and clinical laboratory tests. - Subjects will have a Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs). - Are normotensive with sitting blood pressure between the range of 90 - 140 mm Hg systolic and 50 - 90 mm Hg diastolic. - Have a heart rate of 50-100 beats per minute (bpm). - Have a negative urine drug screen at screening and at check-in to the research unit. - If female of child-bearing potential, a negative pregnancy test at screening and at admission to the clinical research unit. - Able to sign and date the informed consent document, indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. - Received a thorough explanation of the mandatory pharmacogenomic research component of the study and has signed the separate pharmacogenomic informed consent document. - Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: - Extensive restrictions on the type of food and drink allowed - Medical history that precludes inclusion in the trial per protocol - History of allergy and/or sensitivity to loperamide HCl - History of alcohol consumption that precludes inclusion in the trial per protocol - Positive screening test for HIV, Hepatitis B or Hepatitis C - Treatment with an investigational drug within 30 days preceding the first dose of study medication - Females who are pregnant, nursing, or unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in the protocol - Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives prior to first dose - Donated or lost blood or blood products within 3 months of first dose or intention to donate blood or blood products within one month after the last dose - History of sensitivity to heparin or heparin-induced thrombocytopenia - Unwillingness or inability to comply with the Lifestyle Guidelines listed in the protocol - Relationship to persons involved directly with the conduct of the study |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Cetero Research | Fargo | North Dakota |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Consumer and Personal Products Worldwide |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic parameters | Blood samples will be collected before dosing (predose) and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 10, 14, 24, 30, 36, and 46 hours following each of the three doses | No | |
Secondary | Pharmacodynamic Parameter: Urine for Analysis of Cortisol and 6-beta Hydroxycortisol | 8 PM to about 6 AM prior to each dose administration, Day 1, Day 3 and Day 8 | No | |
Secondary | Pharmacodynamic Parameter: Pupillometry Assessments | predose (0) and at 2, 4, 6, 8, and 12 hours after dosing on Day 1, Day 3 and Day 8 | No | |
Secondary | Pharmacogenomic Evaluation - Genotype CYP3A4, CYP3A5, and ABCB1 | pre-dose or post-dose | No | |
Secondary | Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product | throughout duration of the study (+ 30 days for spontaneously reported SAEs) | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04645940 -
Fruquintinib Food Effect and Proton Pump Inhibitor Study
|
Phase 1 | |
Completed |
NCT04540965 -
Impact of a Histamine H2 Receptor Antagonist (H2RA) on the Pharmacokinetics (PK) of Telaglenastat in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04531072 -
Effect of Atazanavir-ritonavir on the Pharmacokinetics and Toxicity of Lumefantrine
|
Phase 4 | |
Completed |
NCT03385525 -
Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074
|
Phase 1 | |
Completed |
NCT05680792 -
Pharmacokinetic Interaction Between Nitazoxanide and Atazanavir/Ritonavir in Healthy Volunteers
|
N/A | |
Completed |
NCT05137548 -
A Drug-Drug Interaction Study Between ATI-2173 and Tenofovir Disoproxil Fumarate in Healthy Subjects
|
Phase 1 | |
Not yet recruiting |
NCT05525351 -
The Application and Validation of Triple Drug Response Surface Models on Density Spectral Array in Clinical Anesthesia
|
||
Terminated |
NCT01980342 -
Pharmacokinetics and Pharmacodynamics of the Etonogestrel Contraceptive Implant When Co-administered With Efavirenz
|
Phase 4 | |
Completed |
NCT04080596 -
DDI Study to Investigate the Impact of Itraconazole on the Pharmacokinetics of Dorzagliatin
|
Phase 1 | |
Recruiting |
NCT04593680 -
Assessment of Drug-drug Interactions Between Masculinizing Hormone Therapy and Antiretroviral Agents Concomitantly for Pre-exposure Prophylaxis Among Transgender Men
|
N/A | |
Active, not recruiting |
NCT04590417 -
Assessment of Drug-drug Interactions Between Feminizing Hormone Therapy and Emtricitabine/Tenofovir Alafenamide Concomitantly for Pre-exposure Prophylaxis Among Transgender Women
|
N/A | |
Completed |
NCT05633147 -
Effect of Clarithromycin on PK of Linaprazan, Linaprazan on PK of Clarithromycin and Linaprazan on PK of Midazolam
|
Phase 1 | |
Completed |
NCT02391688 -
Evaluation of the Potential Pharmacokinetic Interactions Between Probe Drugs in the Geneva Phenotyping Cocktail
|
Phase 1 | |
Completed |
NCT03336346 -
Effect of Dolutegravir on Etonogestrel Levels in HIV-infected Women in Botswana
|
||
Completed |
NCT04818086 -
Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder
|
Phase 1/Phase 2 | |
Completed |
NCT03187015 -
A Study to Examine the Effects of Entinostat on Midazolam in Healthy Adult Subjects
|
Phase 1 | |
Not yet recruiting |
NCT04463576 -
Drug Interactions in Hospital Information System. The PRoSIT System..
|
||
Not yet recruiting |
NCT03920566 -
The Effect of ENZAlutamide on the Anti-Xa Levels of Patients Receiving DOACs
|
||
Completed |
NCT03011996 -
To Investigate PK and PD of CJ-12420, Clarithromycin, Amoxicillin After Multiple Dose Administration
|
Phase 1 | |
Completed |
NCT04902105 -
Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of UGTs on the PK of Ecopipam and Its Active Metabolite
|
Phase 1 |