Recent Updates
Recently added Catalysts

Norvasc

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 20, 2024

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

Norvasc · 2 trials · 1 indication

Phase 1 2
NCT00841542Amlodipine 10 mg Tablets Under Fasting ConditionsHealthy
COMPLETED28 Analytics
NCT00841815Amlodipine 10 mg Tablets Under Fed ConditionsHealthy
COMPLETED28 Analytics
PHASE1COMPLETED
Amlodipine 10 mg Tablets Under Fasting Conditions
Healthy
NCT0084154228
Unlock trial analytics
PHASE1COMPLETED
Amlodipine 10 mg Tablets Under Fed Conditions
Healthy
NCT0084181528
Unlock trial analytics

Study Endpoints

Primary Endpoints

Cmax - Maximum Observed Concentration
Blood samples collected over 168 hour period

Bioequivalence based on Cmax

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Blood samples collected over 168 hour period

Bioequivalence based on AUC0-inf

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Blood samples collected over 168 hour period

Bioequivalence based on AUC0-t

Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Amlodipine BesylateEXPERIMENTALAmlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference) dosed in second period
Norvasc®ACTIVE_COMPARATORNorvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period

Interventions

NameTypeDescription
Amlodipine BesylateDRUG10 mg Tablet
Norvasc®DRUG10 mg Tablet
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria * Non-smoking male or female with a minimum age of 18 years (i.e. non-smoker or non-tobacco user for at least 90 days prior to pre-study medical screening). * Body Mass Index (BMI = weight/height2) greater than or equal to 19.0 kg.m2 and less than or equal to 30.0 kg/m2. * Normal...

Countries:Canada
Unlock Eligibility Criteria

Frequently asked questions about Norvasc

What is Norvasc?

Norvasc is a small molecule drug being developed by Teva Pharmaceutical Industries Limited (TEVA). It is currently in Phase 1 clinical development for healthy volunteers. The drug is being studied in two completed trials with a total enrollment of 56 participants.

What is Norvasc used for?

Norvasc is being studied for use in healthy volunteers. The clinical trials are designed to evaluate the drug under fasting and fed conditions. It is an investigational drug and has not been approved for any indication.

Who makes Norvasc?

Norvasc is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting clinical trials to evaluate the drug in healthy volunteers.

What phase is Norvasc in?

Norvasc is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is still investigational and has not been approved by regulatory authorities.

What clinical trials is Norvasc in?

Norvasc has two completed Phase 1 trials: NCT00841542, a study of amlodipine 10 mg tablets under fasting conditions, and NCT00841815, a study under fed conditions. Both trials enrolled 28 healthy participants each in Canada.

Is Norvasc the same as amlodipine?

Norvasc is the brand name for amlodipine, a calcium channel blocker. The clinical trials listed for Norvasc are specifically for amlodipine 10 mg tablets, indicating that Norvasc and amlodipine refer to the same active ingredient.