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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01053208
First received: January 20, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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 fasting conditions.


Condition Intervention Phase
Healthy
Drug: Ibuprofen and Diphenhydramine Citrate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label,Balanced,Randomized,Two-treatment,Two-sequence,Two Period,Single-dose,Crossover Oral Bioequivalence Study of Ibuprofen and Diphenhydramine Citrate 200mg/38mg Caplets of Dr.Reddy's and Advil®PM of Wyeth in Normal,Healthy,Adult,Human Subjects Under Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence study of Dr. Reddys Laboratories Limited, Ibuprofen and Diphenhydramine Citrate Caplets under fasting condition [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibuprofen and Diphenhydramine Citrate
Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets of Dr. Reddy's
Drug: Ibuprofen and Diphenhydramine Citrate
Ibuprofen and Diphenhydramine Citrate 200mg/38mg Caplets
Other Name: Advil PM
Active Comparator: Advil
Advil PM 200 mg/38 mg Tablets of Wyeth
Drug: Ibuprofen and Diphenhydramine Citrate
Ibuprofen and Diphenhydramine Citrate 200mg/38mg Caplets
Other Name: Advil PM

Detailed Description:

Detailed Description : The study was conducted as an Open label, balanced, randomized, two-treatment, two-sequence, two period,single-dose, crossover 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 Healthcare, USA., in normal, healthy, adult, human subjects under fasting conditions. A total number of forty (40) subjects were enrolled in the study and all the subjects completed both the periods of the study.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Female subjects who are currently breast-feeding.
  • Female subjects with child bearing potential using prohibited contraceptive method (Oral, Injectable or Implantable hormonal agents).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053208

Locations
India
GVK Biosciences Pvt. Ltd
Amirpet, Hyderabad, India, 500 038
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: N. Netaji, MD GVK Biosciences Pvt. Ltd
  More Information

No publications provided

Responsible Party: Director Clinical Pharmacology & Pharmacokinetics, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01053208     History of Changes
Other Study ID Numbers: 149-07
Study First Received: January 20, 2010
Last Updated: January 20, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence,Ibuprofen Diphenhydramine Citrate,Crossover

Additional relevant MeSH terms:
Diphenhydramine
Promethazine
Ibuprofen
Citric Acid
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Antipruritics
Dermatologic Agents
Anticoagulants
Hematologic Agents
Chelating Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on July 29, 2014