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BAY98-7111

Phase 1

Therapeutic Equivalence | Small molecule | Other |Bayer AG|Last Updated: Aug 21, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

BAY98-7111 · 1 trial · 1 indication

Phase 1 1
NCT01666678Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride CombinationTherapeutic Equivalence
COMPLETED32 Analytics
PHASE1COMPLETED
Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination
Therapeutic Equivalence
NCT0166667832
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Study Endpoints

Primary Endpoints

AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of naproxen sodium
within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing
AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of DPH HCL(Diphenhydramine Hydrochloride)
within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing
Cmax(Maximum drug concentration) in plasma of naproxen sodium
within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing
Cmax(Maximum drug concentration) in plasma of DPH HCL(Diphenhydramine Hydrochloride)
within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing

Secondary Endpoints

Number of participants with adverse events as a measure of safety and tolerability
up to 6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2ACTIVE_COMPARATOR -
Arm 3ACTIVE_COMPARATOR -
Arm 4EXPERIMENTAL -

Interventions

NameTypeDescription
BAY98-7111DRUG2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fasting conditions
Naproxen Sodium (Aleve, BAYH6689)DRUG2 x Naproxen Sodium 220 mg under fasting conditions
Diphenhydramine HClDRUG2 x Diphenhydramine HCl 25 mg under fasting conditions
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Health, ambulatory male and female subjects between 18 to 55 years of age inclusive * Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs) * Results of screening and clinical laboratory tests are within normal range or considered not...

Countries:United States
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Frequently asked questions about BAY98-7111

What is BAY98-7111 used for?

BAY98-7111 is an investigational small molecule being studied for therapeutic equivalence. It was evaluated in a Phase 1 clinical trial in the United States to compare the pharmacokinetic profiles of naproxen sodium, diphenhydramine hydrochloride, and a combination of naproxen sodium and diphenhydramine hydrochloride.

Who makes BAY98-7111?

BAY98-7111 is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY. The drug is currently in Phase 1 clinical development.

What phase is BAY98-7111 in?

BAY98-7111 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.

What clinical trials is BAY98-7111 in?

BAY98-7111 has one completed clinical trial, NCT01666678, titled "Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination." The trial enrolled 32 participants in the United States and was an active-controlled, randomized study.

Is BAY98-7111 the same as naproxen sodium or diphenhydramine hydrochloride?

BAY98-7111 is not the same as naproxen sodium or diphenhydramine hydrochloride. The Phase 1 trial compared the pharmacokinetic profiles of these two drugs individually and in combination, with BAY98-7111 being the investigational product under study for therapeutic equivalence.