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Altace

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 19, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials3
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

Altace · 3 trials · 1 indication

Phase 1 3
NCT00828321Ramipril 10 mg Capsule in Healthy Subjects Under Fasting ConditionsHealthy
COMPLETED40 Analytics
NCT00829452Ramipril 10 mg Capsule in Healthy Subjects Under Fasting ConditionsHealthy
COMPLETED40 Analytics
NCT00829530Ramipril 10 mg Capsule in Healthy Subjects Under Fed ConditionsHealthy
COMPLETED40 Analytics
PHASE1COMPLETED
Ramipril 10 mg Capsule in Healthy Subjects Under Fasting Conditions
Healthy
NCT0082832140
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PHASE1COMPLETED
Ramipril 10 mg Capsule in Healthy Subjects Under Fasting Conditions
Healthy
NCT0082945240
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PHASE1COMPLETED
Ramipril 10 mg Capsule in Healthy Subjects Under Fed Conditions
Healthy
NCT0082953040
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Study Endpoints

Primary Endpoints

Cmax (Maximum Observed Concentration of Drug Substance in Plasma)of Ramipril
Blood samples collected over a 72 hour period.

Bioequivalence based on Cmax of Ramipril.

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)of Ramipril
Blood samples collected over a 72 hour period.

Bioequivalence based on AUC0-t of Ramipril.

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)of Ramipril.
Blood samples collected over a 72 hour period.

Bioequivalence based on AUC0-t for Ramipril.

Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramipril.
Blood samples collected over a 72 hour period.

Bioequivalence based on Cmax.

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) for Ramipril.
Blood samples collected over a 72 hour period.

Bioequivalence based on AUC0-t.

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) for Ramipril.
Blood samples collected over a 72 hour period.

Bioequivalence based on AUC0-inf.

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)for Ramipril.
Blood samples collected over a 72 hour period.

Bioequivalence based on AUC0-t.

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)for Ramipril.
Blood samples collected over a 72 hour period.

Bioequivalence based on AUC0-inf.

Secondary Endpoints

Cmax (Maximum Observed Concentration of Drug Substance in Plasma)of Ramiprilat.
Blood samples collected over a 72 hour period.
AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time 72 Hours)of Ramiprilat.
Blood samples collected over a 72 hour period.
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramiprilat.
Blood samples collected over a 72 hour period.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Ramipril 10 mg capsuleDRUG1 x 10 mg
Altace® 10 mg capsuleDRUG1 x 10 mg
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Male or non-childbearing potential female, light smoker of non-smoker 18 years of age and older. * Capable of consent * Non-childbearing potential female subject is defined as follows: * Post-menopausal state: absence of menses for 12 months prior to drug administration or hys...

Countries:Canada
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Frequently asked questions about Altace

What is Altace used for?

Altace is a small molecule drug being developed by Teva Pharmaceutical Industries Limited (TEVA). It is currently in Phase 1 clinical development for use in healthy subjects. The drug is being studied in bioequivalence trials, which are conducted to compare the pharmacokinetics of the drug under fasting and fed conditions.

Who makes Altace?

Altace is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials to evaluate the drug in healthy volunteers. These trials are designed to assess the drug's performance under fasting and fed conditions.

What phase is Altace in?

Altace is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in healthy subjects to evaluate its pharmacokinetic profile. All three completed trials for Altace are Phase 1 studies.

What clinical trials is Altace in?

Altace has been studied in three completed Phase 1 clinical trials: NCT00828321, NCT00829452, and NCT00829530. These trials enrolled a total of 120 healthy subjects in Canada. The studies evaluated ramipril 10 mg capsules under fasting and fed conditions, with each trial enrolling 40 participants.

Is Altace the same as ramipril?

Altace is the brand name for the drug ramipril. The clinical trials for Altace are titled 'Ramipril 10 mg Capsule in Healthy Subjects,' indicating that Altace contains ramipril as its active ingredient. The drug is being studied for its pharmacokinetic profile in healthy volunteers.