NCT02292069

Brief Summary

This study is to assess the bioequivalence between Amlodipine besylate/Atorvastatin calcium Tablets 10mg/80mg of Dr. Reddy's Laboratories Limited, India and CADUET® (amlodipine besylate and atorvastatin calcium) tablets 10mg/80mg of Pfizer Ireland Pharmaceuticals Dublin, Ireland in healthy, adult,human subjects under Fed conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
Last Updated

November 17, 2014

Status Verified

December 1, 2011

Enrollment Period

Same day

First QC Date

November 12, 2014

Last Update Submit

November 12, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Area under curve (AUC)

    The post dose samples of 4.0 mL were drawn at 0.50, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 11.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours for Amlodipine assay

Secondary Outcomes (1)

  • Area under curve (AUC)

    post dose samples of 4.0mL were drawn at 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours for Atorvastatin assay

Study Arms (2)

Amlodipine besylate/Atorvastatin calcium tablets 10/80 mg

EXPERIMENTAL

Amlodipine besylate/Atorvastatin calcium tablets 10/80 mg of Dr. Reddys Laboratories Limited

Drug: Amlodipine besylate/Atorvastatin calcium

Caduet

ACTIVE COMPARATOR

Caduet® 10/80 mg tablets of Pfizer, Ireland

Drug: Amlodipine besylate/Atorvastatin calcium

Interventions

Amlodipine besylate/Atorvastatin calciumDRUG

Amlodipine besylate/Atorvastatin calcium 10/80 mg

Also known as: Caduet
Amlodipine besylate/Atorvastatin calcium tablets 10/80 mgCaduet

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects aged between 18 and 45 years (both inclusive).
  • Subjects' weight within normal range according to normal values for Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg weight.
  • Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.
  • Subjects having normal 12-lead electrocardiogram (ECG).
  • Subjects having normal chest X-Ray (P/A view) whose X-Ray was taken not more than 6 months prior to the dosing of Period 01.
  • Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
  • Subjects having negative alcohol breath test.
  • Subjects willing to adhere to the protocol requirements and to provide written informed consent.

You may not qualify if:

  • Hypersensitivity to Amlodipine and Atorvastatin or related class of drugs.
  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
  • Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
  • History or presence of significant alcoholism or drug abuse.
  • History or presence of significant smoking (more than 10 cigarettes or beedi's/day).
  • History or presence of asthma, urticaria or other significant allergic reactions.
  • History or presence of significant gastric and/or duodenal ulceration.
  • History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
  • History or presence of cancer.
  • Difficulty with donating blood.
  • Difficulty in swallowing solids like tablets or capsules.
  • Use of any prescribed or OTC medication during last two weeks prior to dosing in period 01.
  • Major illness during 3 months before screening.
  • Participation in a drug research study within past 3 months.
  • Donation of blood in the past 3 months before screening.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veeda Clinical Research Pvt Ltd

Ahmedabad, Gujarat, 380 015, India

Location

MeSH Terms

Interventions

AmlodipineAtorvastatinamlodipine, atorvastatin drug combination

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Dr.Gunjan Shah, MD

    Veeda Clinical Research Pvt. Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 17, 2014

Study Start

September 1, 2011

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

November 17, 2014

Record last verified: 2011-12

Locations

IN(1)