HealthyPhase 1NCT00870571
A Relative Bioavailability Study of Amlodipine Besylate 10 mg Tablets Tablets Under Fed Conditions
A Phase 1 study testing AMLODIPINE (as BESILATE) TABLETS 10 mg , single dose and NorvasC® 10 mg Tablets in people with Healthy, run by Actavis Inc. at 1 site in Canada.
Trial summary
The purpose of this study to assess the single-dose relative bioavailability of Actavis Group hf and Pfizer (Norvasc®) 10 mg amlodipine besylate tablets, under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AMLODIPINE (as BESILATE) TABLETS 10 mg , single dose and NorvasC® 10 mg Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2005to May 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:
- Healthy adult male or female volunteers, 18-55 years of age;
- Subject will be non-smokers or moderate smokers (less than 10 cigarettes a day) for at least 3 months.
- Weighing at least 60 kg for males and 52 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);
- Medically healthy subjects with clinically normal laboratory profiles. vital signs and ECGs;
- Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose, throughout the study and for 14 days following the last dose or be using one of the following acceptable birth control methods:
Show all 13Show fewer
- surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum.
- IUD in place for at least 3 months.
- barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose, throughout the study, and for 14 days following the last dose.
- surgical sterilization of the partner (vasectomy for 6 months minimum).
- hormonal contraceptives for at least 3 months prior to the first dose of the study and for 14 days following the last dose.
- Other birth control methods may be deemed acceptable. Postmenopausal women with amenorrhea for at least 2 years will be eligible.
- Give voluntary written informed consent to participate in the study.
Who cannot join
- Subject candidates must not be enrolled in the study if they meet any of the following criteria:
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- In addition, history or presence of:
- alcoholism or drug abuse within the past year;
- hypersensitivity or idiosyncratic reaction to amlodipine or other calcium channel blockers.
- Female subjects who are pregnant or lactating.
Show all 14Show fewer
- SUbjects who tested positive at screening for HIV, HbsAg or HeV.
- Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or 100/55 mmHg before dosing.
- Subjects whose pulse is lower than 55 b.p.m. at screening or 50 b.p.m. prior to dosing.
- Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 10 days prior to the first dose.
- Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
- Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
- Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood In 14 days; 1500 mL of blood in 160 days; 2500 mL of blood In 1 year.
- Subjects who have participated in another clinical trial within 28 days prior to the first dose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative, Randomized, Single Dose, 2-way Crossover Bioavailability Study of Actavis Group hf and Pfizer Inc. (Norvasc®)10 mg Amlodipine Besylate Tablets in Healthy Adult Volunteers Under Fed Conditions.
The purpose of this study to assess the single-dose relative bioavailability of Actavis Group hf and Pfizer (Norvasc®) 10 mg amlodipine besylate tablets, under fed conditions.
Read the detailed description
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Actavis Group hf and Pfizer Inc. (Norvasc®) 10 mg Amlodipine Besylate Tablets in Healthy Adult Volunteers under FedConditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
- Conditions
- Healthy
- Being tested
- AMLODIPINE (as BESILATE) TABLETS 10 mg , single dose, NorvasC® 10 mg Tablets
- Keywords
- Bioequivalence, amlodipine besylate, amlodipine, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMLODIPINE (as BESILATE) TABLETS 10 mg , single doseDrug
Also called amlodipine besylate, amlodipine
A: Experimental Subjects received EMCURE PHARMACEUTICALS LTD. formulated products under fed conditions
NorvasC® 10 mg TabletsDrug
Also called amlodipine besylate, amlodipine
B: Active comparator Subjects received Pfizer Labs Division of Pfizer Inc. formulated products under fed conditions
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | AMLODIPINE (as BESILATE) TABLETS 10 mg, single dose Receives: Drug: AMLODIPINE (as BESILATE) TABLETS 10 mg , single dose |
| B | Active comparator | NorvasC® 10 mg Tablets, single dose Receives: Drug: NorvasC® 10 mg Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and Extend of Absorption
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startApr 2005
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gaetano Morelli,, MD, Principal investigator, MDS Pharma Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870571
- Sponsor's protocol ID
- 24309
- Status last verified
- Aug 2010
- First submitted
- 26 Mar 2009
- Last updated
- 16 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Randomized, Single Dose, 2-way Crossover Bioavailability Study of Actavis Group hf and Pfizer Inc. (Norvasc®)10 mg Amlodipine Besylate Tablets in Healthy Adult Volunteers Under Fed Conditions.
- ClinicalTrials.gov ID
- NCT00870571
- Acronym / sponsor ID
- 24309
- Conditions
- Healthy
- Keywords
- Bioequivalence, amlodipine besylate, amlodipine, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 27 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study to assess the single-dose relative bioavailability of Actavis Group hf and Pfizer (Norvasc®) 10 mg amlodipine besylate tablets, under fed conditions.
Detailed description
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Actavis Group hf and Pfizer Inc. (Norvasc®) 10 mg Amlodipine Besylate Tablets in Healthy Adult Volunteers under FedConditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: AMLODIPINE (as BESILATE) TABLETS 10 mg , single doseAMLODIPINE (as BESILATE) TABLETS 10 mg, single dose |
| B | Active comparator | Drug: NorvasC® 10 mg TabletsNorvasC® 10 mg Tablets, single dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:
- Healthy adult male or female volunteers, 18-55 years of age;
- Subject will be non-smokers or moderate smokers (less than 10 cigarettes a day) for at least 3 months.
- Weighing at least 60 kg for males and 52 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);
- Medically healthy subjects with clinically normal laboratory profiles. vital signs and ECGs;
Key exclusion criteria (14 listed)
- Subject candidates must not be enrolled in the study if they meet any of the following criteria:
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- In addition, history or presence of:
- alcoholism or drug abuse within the past year;
- hypersensitivity or idiosyncratic reaction to amlodipine or other calcium channel blockers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMLODIPINE (as BESILATE) TABLETS 10 mg , single doseAlso: amlodipine besylate, amlodipineA: Experimental Subjects received EMCURE PHARMACEUTICALS LTD. formulated products under fed conditions | Drug | A |
| NorvasC® 10 mg TabletsAlso: amlodipine besylate, amlodipineB: Active comparator Subjects received Pfizer Labs Division of Pfizer Inc. formulated products under fed conditions | Drug | B |
Primary outcome
Rate and Extend of Absorption
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2010.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaetano Morelli,, MD principal investigator
MDS Pharma Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMLODIPINE (as BESILATE) TABLETS 10 mg , single dose and NorvasC® 10 mg Tablets in people with Healthy, run by Actavis Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate and Extend of Absorption (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2010.