NCT00778037

Brief Summary

To compare the single-dose oral bioavailability of Cyclobenzaprine hydrochloride 10 mg tablet of Ohm Labs Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc USA.) with Flexeril® 10 mg tablet (containing Cyclobenzaprine hydrochloride 10 mg) of McNeil Consumer \& Specialty Pharmaceuticals, in healthy, adult, male, human subjects under fasting condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Sep 2006

Shorter than P25 for not_applicable 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, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed
Last Updated

October 23, 2008

Status Verified

October 1, 2008

Enrollment Period

Same day

First QC Date

October 22, 2008

Last Update Submit

October 22, 2008

Conditions

Healthy

Keywords

Bioequivalence Cyclobenzaprine hydrochloride 10 mg tablet fasting conditions

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence

Study Arms (2)

1

EXPERIMENTAL

Cyclobenzaprine hydrochloride 10 mg tablet of ranbaxy

Drug: Cyclobenzaprine hydrochloride 10 mg tablet

2

ACTIVE COMPARATOR

Flexeril® 10 mg tablets

Drug: Cyclobenzaprine hydrochloride 10 mg tablet

Interventions

Cyclobenzaprine hydrochloride 10 mg tabletDRUG
12

Eligibility Criteria

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

You may qualify if:

  • Were in the age range of 18-45 years.
  • Were neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
  • Had voluntarily given written informed consent to participate in this study
  • Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.

You may not qualify if:

  • \- Hypersensitivity or allergy to Cyclobenzaprine hydrochloride or related group of drugs.
  • Use of MAO Inhibitors in the past 2 weeks / history of Hyperthyroidism.
  • History of hypotension, dizziness, syncope or those who had previously experienced a hypotensive response to other medications.
  • History of arrhythmia, heart block or congestive heart failure.
  • History of urinary disorders especially urinary retention.
  • History of seizures, tinnitus, tremors, visual disorders, psychosomatic illness, recurrent palpitations, Jaundice.
  • Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
  • Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
  • Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count.
  • Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)
  • Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.
  • Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (\>4/HPF), epithelial cells (\>4/HPF), glucose (positive) or protein (positive).
  • Clinically abnormal ECG or Chest X-ray.
  • History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes, glaucoma or increased intra ocular pressure.
  • History of any psychiatric illness which might impair the ability to provide written informed consent.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ranbaxy CPU

Gurgaon, Haryana, India

Location

Related Links

MeSH Terms

Interventions

cyclobenzaprineTablets

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 23, 2008

Study Start

September 1, 2006

Primary Completion

September 1, 2006

Study Completion

November 1, 2006

Last Updated

October 23, 2008

Record last verified: 2008-10

Locations

IN(1)