Clinical TrialID 6132
Drug-Drug Interaction Study of Qualaquin and Midazolam
NCT00785486
Healthy
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 6132
- Evidence Id
- 6132
- Core Evidence Id
- 6132
- Source Clinical Trial Id
- 6118
- Herb2 Clinical Trial Id
- HBCT006118
- Nct Id
- NCT00785486
- Title
- Drug-Drug Interaction Study of Qualaquin and Midazolam
- Status
- Completed
- Phase
- Phase 1
- Study Result
- Yes
- Study Condition
- Healthy
- Study Type
- Interventional
- Study Design
- Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
- Intervention
- DRUG: Midazolam Alone|DRUG: Qualaquin (quinine) alone steady state|DRUG: Midazolam and Qualaquin at steady state
- Intervention Allocation
- Non_Randomized
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Basic_Science
- Gender
- All
- Age
- Adult
- Enrollment
- 24
- Outcome Measure
- Maximum Serum Concentration (Cmax), Maximum serum concentration(Cmax), Day 1 (Midazolam Alone), Day 9 (Qualaquin (quinine) Alone), Day 10 Midazolam with Qualaquin (quinine)|Area Under the Concentration Time Curve From Zero to T (AUC 0-t) for Midazolam and 1-hydroxy Midazolam at Baseline and With Qualaquin (Quinine) at Steady State., Area under the concentration time curve(AUC 0-t) calculated by the linear trapezoidal method from time 0 to 24 hours, for Midazolam and 1-hydroxy-midazolam on day 1 (midazolam alone) and day 10 (midazolam with Qualaquin -(quinine) at steady state to determine if a significant drug interaction occurs between midazolam and quinine, Days 1 and 10 at 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours|Area Under the Concentration Time Curve From Zero to Infinity (AUC Inf) for Midazolam and 1 Hydroxy Midazolam Before (Day 1) and After (Day 10) Qualaquin (Quinine)., AUC inf for Midazolam and hydroxy-midazolam on day 1 (midazolam alone) and day 10 (midazolam with steady state Qualaquin(quinine)- the sum of AUC0-t plus the ratio of the last measured plasma concentration to the elimination rate constant to determine whether a significant drug interaction occurs between midazolam and quinine, Days 1 and 10 at 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours|The Area Under the the Concentration Time Curve From Zero to Tau (0-8hrs) for Qualaquin (Quinine) AUC Tau Before and After Midazolam, Qualaquin (quinine) - AUC tau alone at steady state (day 9) and in the presence of coadministered midazolam 2 mg (day 10) over the dosing interval (0 - 8 hours), as calculated by the linear trapezoidal method., Days 9 and 10 at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 7.917 hours
- Sponsor Collaborator
- Mutual Pharmaceutical Company, Inc.
- Funded By
- INDUSTRY
- Location
- MDS Pharma Services, Phoenix, Arizona, 85044, United States
- Other Id
- MPC-001-07-1001
- Start Date
- 2007-03
- Primary Completion Date
- 2007-03
- Completion Date
- 2007-03
- First Posted
- 2008-11-05
- Results First Posted
- 2009-07-08
- Last Update Posted
- 2012-08-31
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT00785486
- Title Cn
- Title En
- Drug-Drug Interaction Study of Qualaquin and Midazolam
- Bilingual Status
- semi_complete