Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fed Condition

NCT01053338 | Completed Phase 1

• 1 other identifier: 155-07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the single-dose oral bioequivalence study of Ibuprofen and Diphenhydramine citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil®PM, of Wyeth consumer health care, USA, in normal, healthy, adult, human subjects under fed conditions.

Conditions

Healthy

Keywords

Bioequivalence,Ibuprofen Diphenhydramine Citrate,Crossover

Outcome Measures

Primary Outcomes (1)

• Bioequivalence study of Dr. Reddys Laboratories Limited, Ibuprofen and Diphenhydramine Citrate Caplets under fasting condition

  2 months

Study Arms (2)

Ibuprofen and Diphenhydramine Citrate

EXPERIMENTAL

Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets of Dr. Reddy's

Drug: Ibuprofen and Diphenhydramine Citrate

Advil

ACTIVE COMPARATOR

Advil PM 200 mg/38 mg Tablets of Wyeth

Drug: Ibuprofen and Diphenhydramine Citrate

Interventions

Ibuprofen and Diphenhydramine Citrate DRUG

Ibuprofen and Diphenhydramine Citrate 200mg/38mg Caplets

Also known as: Advil PM

Advil; Ibuprofen and Diphenhydramine Citrate

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy human subjects aged between 18 and 45 years (including both).
• Subjects with a BMI between 18.5 - 24.9 Kg/m2 (including both) but body weight not less than 45 Kgs.
• Subjects with normal health as determined by personal medical history, clinical examination, and laboratory examinations including serological tests.
• Subjects having normal 12 lead electrocardiogram (ECG).
• Subjects having normal chest X-Ray (P/A view).
• Subjects able to communicate effectively.
• Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
• Female subjects who are postmenopausal or surgically sterile.
• Female subjects practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm,intrauterine device (IUD) or abstinence.

You may not qualify if:

• Subjects having contraindications or hypersensitivity to Ibuprofen Diphenhydramine citrate or related group of drugs.
• History or presence of any medical conditions or disease according to the opinion of the physician.
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
• History or presence of significant alcoholism or drug abuse in the past one year.
• History or presence of significant smoking (more than 10 cigarettes or bidis/day or consumption of tobacco products).
• Difficulty with donating blood.
• Difficulty in swallowing solids like tablets or capsules.
• Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg.
• Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
• Pulse rate less than 50 beats/minute or more than 100 beats/minute.
• Use of any prescribed medication during last two weeks or OTC medicinal products during the last one week preceding the first dosing.
• 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.
• Female subjects demonstrating a positive pregnancy screen.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

GVK Biosciences Pvt. Ltd

Amīrpet, Hyderabad, 500 038, India

Location

MeSH Terms

Interventions

Ibuprofen; Diphenhydramine

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Ethylamines; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• N. Netaji, MD

  GVK Biosciences 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: January 20, 2010
• First Posted: January 21, 2010
• Study Start: April 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: January 21, 2010

Record last verified: 2010-01

Locations

IN (1)