Drug-Drug Interaction Study of Qualaquin and Midazolam
Study Details
Study Description
Brief Summary
This is an open label non-randomized single sequence, single group two way drug interaction study in healthy adult volunteers to determine the extent to which quinine, an inducer of cytochrome p450 CYP 3A4, affects the pharmacokinetics of midazolam, an accepted probe drug for CYP 3A4. The study will also determine the extent to which midazolam affects the pharmacokinetics of quinine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This is an open label single sequence single group non-randomized two way drug interaction study in healthy adult volunteers to determine the extent to which quinine, an inducer of cytochrome p450 CYP 3A4, affects the pharmacokinetics of midazolam, an accepted probe drug for CYP 3A4. The study will also determine the extent to which midazolam affects the pharmacokinetics of quinine. This will compare the pharmacokinetics of midazolam and quinine at baseline to their kinetics when they are taken together in 24 normal healthy adult volunteers who will serve as their own controls. All patients will be confined to the study site throughout the entire 11 day study period. On day 1 after a fast of at least 10 hours, all study participants will receive a single oral dose of midazolam 2 mg. Blood will be drawn at times sufficient to adequately define the baseline concentration time curve for midazolam and its metabolite, 1-hydroxy-midazolam. On the morning of day 4, after a 3 day washout period and following a fast of at least 10 hours, all volunteers will begin a regimen of 324 mg of quinine sulfate by mouth every 8 hours. All subjects will continue this regimen from day 4-10 (21 total doses). Blood will be drawn after the first daily dose of quinine on days 4 and 9 at times sufficient to adequately define the baseline and steady state concentration time curves for quinine. Additional blood will be drawn prior to the first daily dose of quinine on days 7,8,9,and 10. On day 10 after a fast of at least a 10 hours, all participants will receive both midazolam 2 mg and quinine 324 mg together. Blood will be drawn a times sufficient to characterize the pharmacokinetics of midazolam, 1-hydroxy-midazolam and quinine under the stated conditions.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Midazolam alone Baseline midazolam and 1-hydroxy-midazolam pharmacokinetics. One day 1 after a fast of at least 10 hours patients received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to characterize the pharmacokinetics of midazolam and its main metabolite. |
Drug: Midazolam Alone
Midazolam 2 mg syrup was given orally after a fast of at least 10 hours.
Other Names:
|
| Other: Qualaquin (quinine) alone steady state On the morning of day 9 after taking Qualaquin (quinine) capsules 324 mg orally every 8 hours for the prior 5 days, and following a fast of at least 10 hours all study participants received their usual morning dose of Qualaquin (quinine) 324 mg. Blood was drawn at times sufficient to determine the steady state Cmax and AUC 0-tau for Qualaquin (quinine). |
Drug: Qualaquin (quinine) alone steady state
Qualaquin (quinine) 324 mg capsules were given orally every 8 hours for 7 days ( 21 doses total). On day 9 after taking Qualaquin (quinine) for 5 days according to the stated regimen and fasting for at least 10 hours, all participants took their usual dose of Qualaquin (quinine). Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine at steady state
Other Names:
|
| Experimental: Midazolam with Qualaquin (quinine) On day 10 after taking Qualaquin (quinine) for 6 days according to the stated regimen, all participants took their usual dose of Qualaquin (quinine) with an oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize the steady state kinetics of quinine and the kinetics of midazolam and 1-hydroxy-midazolam in the presence of each other. |
Drug: Midazolam and Qualaquin at steady state
On the morning of day 10 after taking Qualaquin (quinine) for 6 days according to the stated regimen (324 mg every 8 hours), all participants took their usual dose of Qualaquin (quinine) with an oral dose of midazolam 2 mg after a fast of at least 10 hours
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Maximum Serum Concentration (Cmax) [Day 1 (Midazolam Alone), Day 9 (Qualaquin (quinine) Alone), Day 10 Midazolam with Qualaquin (quinine)]
Maximum serum concentration(Cmax)
- 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. [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(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
- 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). [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]
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
- The Area Under the the Concentration Time Curve From Zero to Tau (0-8hrs) for Qualaquin (Quinine) AUC Tau Before and After Midazolam [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]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Medically healthy non-smoking, non-obese (≥ 60 kg males, ≥52 kg females within 15% of IBW) adult volunteers 18-45 years of age
Exclusion Criteria:
-
Subjects with history or presence of significant cardiovascular disease (including hypotension, hypertension, bradycardia or EKG abnormalities), pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease or an active sexually transmitted disease.
-
Subjects with significant blood loss in the prior 56 days, plasma donation within 7 days , hemoglobin < 12.0 g/dl or who have participated in another clinical trial within the prior 30 days.
-
Subjects with recent (2-year) history or evidence of alcoholism or drug abuse.
-
Subjects who have used any drugs or substances known to inhibit or induce cytochrome P450 (CYP) enzymes 10 days or 28 days respectively prior to the first dose and throughout the study.
-
Subjects who have received monoamine oxidase inhibitors or been on a special diet within 28 days of starting the study.
-
Subjects who test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV).
Subjects who are pregnant or lactating, taking hormone replacement therapy or have known allergies to quinine sulfate, mefloquine, quinidine or midazolam and other benzodiazepines.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MDS Pharma Services | Phoenix | Arizona | United States | 85044 |
Sponsors and Collaborators
- Mutual Pharmaceutical Company, Inc.
Investigators
- Study Chair: Matthew Davis, MD, Mutual Pharmaceutical
- Principal Investigator: Dennis Swearingen, MD, MDS Pharma Services
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Recalls, Market Withdrawals and Safety Alerts
- Daily Med - Posting of Recently Submitted Labeling to the FDA
Publications
None provided.- MPC-001-07-1001
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Qualaquin (Quinine) And Midazolam Alone And In Combination |
|---|---|
| Arm/Group Description | All pharmacokinetic studies were begun after a fast of at least 10 hours. On day 1 all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to define the baseline kinetics of midazolam and 1-hydroxy-midazolam. After a 3 day washout period, on the morning of day 4, all participants began a regimen of 324 mg of quinine sulfate orally every 8 hours for a total of 21 doses. On day 9 after taking Qualaquin (quinine) for 5 days according to the stated regimen all participants took their usual dose of Qualaquin (quinine). Blood was drawn sufficient to characterize the steady state kinetics of quinine. On day 10 after taking Qualaquin (quinine) for 6 days according to the stated regimen, all participants took their usual dose of Qualaquin (quinine) with an oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize the steady state kinetics of quinine and the kinetics of midazolam and 1-hydroxy-midazolam in the presence of each other. |
| Period Title: Midazolam Alone | |
| STARTED | 24 |
| COMPLETED | 23 |
| NOT COMPLETED | 1 |
| Period Title: Midazolam Alone | |
| STARTED | 23 |
| COMPLETED | 23 |
| NOT COMPLETED | 0 |
| Period Title: Midazolam Alone | |
| STARTED | 23 |
| COMPLETED | 23 |
| NOT COMPLETED | 0 |
| Period Title: Midazolam Alone | |
| STARTED | 23 |
| COMPLETED | 23 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Qualaquin (Quinine) And Midazolam Alone And In Combination |
|---|---|
| Arm/Group Description | All pharmacokinetic studies were begun after a fast of at least 10 hours. On day 1 all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to define the baseline kinetics of midazolam and 1-hydroxy-midazolam. After a 3 day washout period, on the morning of day 4, all participants began a regimen of 324 mg of quinine sulfate orally every 8 hours for a total of 21 doses. On day 9 after taking Qualaquin (quinine) for 5 days according to the stated regimen all participants took their usual dose of Qualaquin (quinine). Blood was drawn sufficient to characterize the steady state kinetics of quinine. On day 10 after taking Qualaquin (quinine) for 6 days according to the stated regimen, all participants took their usual dose of Qualaquin (quinine) with an oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize the steady state kinetics of quinine and the kinetics of midazolam and 1-hydroxy-midazolam in the presence of each other. |
| Overall Participants | 24 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
31.1
(5.6)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
12
50%
|
| Male |
12
50%
|
| Region of Enrollment (participants) [Number] | |
| United States |
24
100%
|
Outcome Measures
| Title | Maximum Serum Concentration (Cmax) |
|---|---|
| Description | Maximum serum concentration(Cmax) |
| Time Frame | Day 1 (Midazolam Alone), Day 9 (Qualaquin (quinine) Alone), Day 10 Midazolam with Qualaquin (quinine) |
Outcome Measure Data
| Analysis Population Description |
|---|
| per protocol |
| Arm/Group Title | Midazolam - Midazolam Alone | 1-Hydroxy-Midazolam - Midazolam Alone | Quinine - Qualaquin(Quinine) Alone | Midazolam - Midazolam With Qualaquin(Quinine) | 1-Hydroxy-Midazolam -Midazolam With Qualaquin(Quinine) | Quinine - Qualaquin (Quinine) With Midazolam |
|---|---|---|---|---|---|---|
| Arm/Group Description | On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours to determine the baseline Cmax for midazolam. | On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours to determine the baseline Cmax for 1-hydroxy-midazolam, the primary metabolite of midazolam | On the morning of day 9 after taking Qualaquin(quinine)capsules 324 mg orally every 8 hours for the prior 5 days, and following a fast of at least 10 hours all study participants received their usual morning dose of Qualaquin (quinine)324 mg. Blood was drawn at times 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 7.917 hours to determine the steady state Cmax for Qualaquin (quinine) at this dose. | On the morning of day 10, after a fast of at least 10 hours all study participants received an oral dose of both midazolam 2 mg and Qualaquin(quinine)324 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917. 12, 15 and 24 hours to determine Cmax for midazolam in the presence of Qualaquin (qunine)at steady state. | On the morning of day 10, after a fast of at least 10 hours all study participants received an oral dose of both midazolam 2 mg and Qualaquin(quinine)324 mg concurrently. On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours to determine the Cmax for 1-hydroxy-midazolam in the presence of Qualaquin (quinine) at steady state. | On the morning of day 10 after taking Qualaquin (quinine)capsules 324 mg orally every 8 hours for the prior 6 days, and following a fast of at least 10 hours all study participants co-ingested oral dose s of midazolam 2 mg and their usual morning dose of Qualaquin (quinine)324 mg. Blood was drawn at times 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 7.917 hours to determine the steady state Cmax for Qualaquin (quinine)in the presence of midazolam. |
| Measure Participants | 23 | 23 | 23 | 23 | 23 | 23 |
| Mean (Standard Deviation) [ng/ml] |
12.0435
(3.53669)
|
4.6907
(2.17605)
|
4432.4089
(678.36810)
|
12.5585
(3.51110)
|
4.8605
(1.82141)
|
4399.7690
(671.04523)
|
| Title | 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. |
|---|---|
| Description | 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 |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| by protocol |
| Arm/Group Title | Midazolam - Midazolam Alone | 1-Hydroxy-Midazolam - Midazolam Alone | Midazolam - Midazolam With Qualaquin (Quinine) | 1-Hydroxy-Midazolam -Midazolam With Qualaquin (Quinine) |
|---|---|---|---|---|
| Arm/Group Description | On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) of midazolam and 1-hydroxymidazolam | On day 1 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) of 1-hydroxy midazolam as calculated by the linear trapezoidal method. | On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin (quinine) 324 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) for midazolam in the presence of Qualaquin(quinine)at steady state as calculated by the linear trapezoidal method. | On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin (quinine) 324 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) for 1-hydroxy midazolam in the presence of Qualaquin(quinine)at steady state as calculated by the linear trapezoidal method. |
| Measure Participants | 23 | 23 | 23 | 23 |
| Mean (Standard Deviation) [ng•h/mL] |
30.076
(10.1593)
|
10.780
(6.6534)
|
27.242
(6.5008)
|
10.454
(5.2714)
|
| Title | 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). |
|---|---|
| Description | 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 |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| per protocol |
| Arm/Group Title | Midazolam - Midazolam Alone | 1-Hydroxy-Midazolam - Midazolam Alone | Midazolam - Midazolam With Qualaquin (Quinine) | 1-Hydroxy-Midazolam -Midazolam With Qualaquin (Quinine) |
|---|---|---|---|---|
| Arm/Group Description | On day 1 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize AUC inf for midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant | On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize AUC inf for 1-hydroxy-midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant. | On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin (quinine) 324 mg . Blood was drawn sufficient to characterize AUC inf for midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant | On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin(quinine) 324 mg. Blood was drawn sufficient to characterize AUC inf for 1- hydroxy-midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant |
| Measure Participants | 23 | 23 | 23 | 23 |
| Mean (Standard Deviation) [ng·h/mL] |
31.324
(10.0930)
|
11.669
(7.4340)
|
28.771
(6.8081)
|
11.447
(5.8587)
|
| Title | The Area Under the the Concentration Time Curve From Zero to Tau (0-8hrs) for Qualaquin (Quinine) AUC Tau Before and After Midazolam |
|---|---|
| Description | 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. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| per protocol |
| Arm/Group Title | Qualaquin (Quinine) Alone | Qualaquin (Quinine) With Midazolam |
|---|---|---|
| Arm/Group Description | On the morning of day 9 after taking an oral dose of Qualaquin quinine)324 mg every 8 hours for the prior 5 days (Steady state) and following a fast of at least 10 hours all participants took a an additional 324 mg oral dose of the drug. Blood was drawn sufficient to determine the pharmacokinetics of Qualaquin(Quinine) alone over the following dosing interval (0 - 8 hours), as calculated by the linear trapezoidal method. | On day 10 after six days of receiving Qualaquin 324 mg every 8 hours, and after a fast of at least 10 hours, patients received a 2 mg dose of midazolam and 324 mg of Qualaquin (quinine)(Steady state). Blood was drawn sufficient to determine the pharmacokinetics of Qualaquin(quinine) in the presence of midazolam over the final dosing interval (0 - 8 hours), as calculated by the linear trapezoidal method. |
| Measure Participants | 23 | 23 |
| Mean (Standard Deviation) [ng•h/mL] |
30455.4
(5028.27)
|
30568.7
(4851.10)
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Midazolam Alone | Qualaquin (Quinine) Alone | Midazolam With Qualaquin (Quinine) Together | |||
| Arm/Group Description | Adverse effects on day 1 after participants received 2mg of midazolam syrup orally. | Adverse effects(ADR)while taking Qualaquin(quinine)324 mg alone orally every 8 hours on days 4-11. Results are reported as total for the 7 day period. | Adverse effects reported on day 10 after participants received 2 mg of midazolam syrup and 324 mg of Qualaquin(quinine)orally. | |||
All Cause Mortality |
||||||
| Midazolam Alone | Qualaquin (Quinine) Alone | Midazolam With Qualaquin (Quinine) Together | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Midazolam Alone | Qualaquin (Quinine) Alone | Midazolam With Qualaquin (Quinine) Together | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/24 (0%) | 0/23 (0%) | 0/23 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Midazolam Alone | Qualaquin (Quinine) Alone | Midazolam With Qualaquin (Quinine) Together | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/ (NaN) | 27/ (NaN) | 4/ (NaN) | |||
| Ear and labyrinth disorders | ||||||
| Tinnitis | 1/23 (4.3%) | 1 | 4/23 (17.4%) | 4 | 0/23 (0%) | 0 |
| Ear Discomfort | 0/23 (0%) | 0 | 3/23 (13%) | 3 | 0/23 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Nausea | 0/23 (0%) | 0 | 3/23 (13%) | 3 | 1/23 (4.3%) | 1 |
| General disorders | ||||||
| Feeling Hot | 0/23 (0%) | 0 | 4/23 (17.4%) | 4 | 0/23 (0%) | 0 |
| Nervous system disorders | ||||||
| Headache | 0/23 (0%) | 0 | 10/23 (43.5%) | 10 | 3/23 (13%) | 3 |
| Tremor | 0/23 (0%) | 0 | 3/23 (13%) | 3 | 0/23 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Medical Affairs Director |
|---|---|
| Organization | Mutual Pharmaceutical Company, Inc. |
| Phone | 215-697-1743 |
| clinicaltrials@urlmutual.com |
- MPC-001-07-1001