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Sponsored by: |
Mutual Pharmaceutical Company, Inc. |
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Information provided by: | Mutual Pharmaceutical Company, Inc. |
ClinicalTrials.gov Identifier: | NCT00779259 |
In a prior in vitro study using human hepatocytes quinine was shown to induce the activity of Cytochrome p450 CYP 1A2. The present study will evaluate the extent to which quinine sulfate-related induction of this enzyme affects the pharmacokinetics of theophylline, a sensitive probe drug for the activity of CYP 1A2.
Condition | Intervention | Phase |
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Healthy |
Drug: Theophylline |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Pharmacokinetic Drug-Drug Interaction Study to Evaluate the Effect of Steady State Quinine Sulfate on Single-Dose Theophylline Pharmacokinetics in Healthy Adult Males |
Enrollment: | 24 |
Study Start Date: | August 2007 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Baseline theophylline kinetics
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Drug: Theophylline
300mg
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2: Experimental
Theophylline kinetics in the presence of steady state quinine 648mg
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Drug: Theophylline
Theophylline with steady state quinine
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3: Experimental
(Optional low dose quinine) Theophylline kinetics in the presence of steady state quinine 324mg
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Drug: Theophylline
Theophylline with steady state quinine (324mg)
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This study will compare the pharmacokinetics of theophylline alone and in the presence of quinine sulfate at steady state. In this non-blinded crossover study 24 normal healthy, non-smoking, non-obese male volunteers will serve as their own controls in two cohorts of 12 volunteers each. On day 1 after a minimum overnight fast of 10 hours, study participants will receive a single oral dose theophylline 300mg. Blood will be drawn at times sufficient to adequately define the baseline concentration time curve for this drug. After a 3 day washout period the 12 volunteers will begin a 7 day course of quinine sulfate 648 mg every 8 hours. If ≥ 62.5% of the volunteers in cohort one do not tolerate the 648mg dose of quinine sulfate, the second cohort of 12 volunteers will receive 324mg doses according to the originally stated dosing regimen. On day 11 blood will be drawn from volunteers in both cohorts sufficient to adequately characterize the steady state kinetics of quinine sulfate. On the morning of day 12 after a fast of at least 10 hours the volunteers will receive both quinine sulfate 648mg and theophylline 300mg. In both cohorts blood will be drawn at times sufficient to adequately define the concentration time curve for both a single dose theophylline in the presence of quinine sulfate at steady state and steady state quinine in the presence of theophylline. The concentration time curves generated will be compared to determine the extent of the drug drug interactions.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, North Dakota | |
PRACS Institute | |
Fargo, North Dakota, United States, 58104 |
Study Chair: | Matthew Davis, MD | Mutual Pharmaceutical |
Principal Investigator: | Barrie March, MD | PRACS Institute |
Responsible Party: | Mutual Pharmaceutical Company, Inc. ( Vice President, Branded Products and Medical Affairs ) |
Study ID Numbers: | MPC-001-07-1002, R07-0738 |
Study First Received: | October 22, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00779259 |
Health Authority: | United States: Food and Drug Administration |
quinine sulfate theophylline drug interactions cytochrome p450 |
humans male adult drug interactions |
Quinine Healthy Theophylline |
Anti-Infective Agents Respiratory System Agents Antiprotozoal Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents Neuromuscular Agents Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions Antimalarials |
Antiparasitic Agents Phosphodiesterase Inhibitors Sensory System Agents Analgesics, Non-Narcotic Autonomic Agents Muscle Relaxants, Central Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents |