Bioequivalence Study of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets Under Fed Conditions

NCT01132222 | Completed Phase 1 DMC

• 1 other identifier: 431-04
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the bioequivalence of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg under fed conditions.

Conditions

Healthy

Keywords

Bioequivalence; Crossover; Ibuprofen and Pseudoephedrine

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUC parameters

  2 months

Study Arms (2)

Ibuprofen + Psuedoephedrine Hydrochloride

EXPERIMENTAL

Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets

Drug: Ibuprofen + Pseudoephedrine Hydrochloride

Advil® Cold and Sinus

ACTIVE COMPARATOR

Advil® Cold and Sinus Tablets of Wyeth Consumer Healthcare

Drug: Ibuprofen + Pseudoephedrine Hydrochloride

Interventions

Ibuprofen + Pseudoephedrine Hydrochloride DRUG

Ibuprofen 200 mg + Pseudoephedrine Hydrochloride 30 mg Tablets

Also known as: Advil® Cold and Sinus

Advil® Cold and Sinus; Ibuprofen + Psuedoephedrine Hydrochloride

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy human subjects between 18-50 years of age (inclusive), weighing as per the standard height and weight chart of Life Insurance Corporation of India (II Underweight and Overweight Min. \& Max. Chart)
• Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21 days to commencement of the study.
• Subjects whose screening laboratory values are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance.
• Informed consent given in written form according to section 10.3 of the protocol.
• Female Subjects:
• of child bearing potential practicing an acceptable method of birth control for the duration of study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
• postmenopausal for at least 1 year.
• surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject.

You may not qualify if:

• History or presence of significant:
• i. Cardiovascular, pulmonary, hepatic, renal hematological; gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
• Alcohol dependence, alcohol abuse or drug abuse within past one year.
• Moderate to heavy smoking (\> 10 cigarettes/day) or on assumption of tobacco products.
• History of difficulty in swallowing.
• Clinically significant illness within 4 weeks before the start of the study
• Asthma, urticaria or other allergic type reactions after taking any medication.
• Subjects who, through completion of the study, would have donated in excess of
• ml of blood in 14 days, or
• m l of blood in 14 days (unless approved by the Principal Investigator)
• ml of blood in 90 days
• ml of blood in 120 days
• ml of blood in 180 days
• ml of blood in 270 days
• ml of blood in 1 year

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Lotus Labs Pvt. Ltd.

Bangalore, Karnataka, 560034, India

Location

MeSH Terms

Interventions

Ibuprofen; Pseudoephedrine

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Vijayanthi G, MBBS, MD

  Lotus Labs Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 27, 2010
• Study Start: September 1, 2004
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: June 14, 2010

Record last verified: 2010-06

Locations

IN (1)