Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01283841
Other study ID # 291-07
Secondary ID
Status Completed
Phase Phase 1
First received January 24, 2011
Last updated January 25, 2011
Start date November 2007
Est. completion date December 2007

Study information

Verified date January 2011
Source Dr. Reddy's Laboratories Limited
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in healthy, adult, human male subjects under fasting conditions and to assess the bioequivalence.


Description:

This was an open-label, balanced, randomized, two-treatment, four-period, two-sequence,single dose, replicate crossover bioequivalence study in healthy, adult, human, male subjects under fasting conditions.48 healthy male adults were enrolled.A washout period of 07 days was maintained between the successive dosing days.One tablet containing mycophenolate mofetil 500 mg was administered orally with 240 mL water in sitting posture, after an overnight fast of at least 10 hours in each period. This activity was followed by a mouth check to assess compliance to dosing. The subjects were not allowed to lie down for the first three hours after dosing.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

1. Healthy males between 18-45 years of age (both inclusive) living in and around Mumbai city of western part of India.

2. Having a weight more than or equal to 50 Kg and having a Body Mass Index (BMI)between 18.5-24.9 (both inclusive), calculated as weight in kg / height in m2.

3. Having no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and chest X-ray (postero-anterior view) recordings.

4. Able to comply with the study procedures, in the opinion of the Principal Investigator.

5. Able to give written consent for participation in the trial.

Exclusion Criteria:

1. Known hypersensitivity or idiosyncratic reaction to Mycophenolate Mofetil or any drug.

2. Any disease or condition which might compromise the haemopoietic, renal, hepatic,endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological,gastrointestinal or any other body system.

3. Ingestion of a medicine at any time with in 14 days before dosing in Period-I. In any such case subject selection will be at the discretion of the Principal Investigator /Medical Expert.

4. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria.

5. A recent history of alcoholism (<2 years) or of moderate (180 mL / day) alcohol use, or consumption of alcohol within 48 hours of receiving study medicine.

6. Smokers, who had a habit of smoking 10 or more than 10 cigarettes / day or could, not abstain from smoking during the study.

7. The presence of clinically significant abnormal laboratory values during screening.

8. Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug scan.

9. History of psychiatric disorders.

10. A history of difficulty with donating blood.

11. Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of the study medicine or during the study.

Note: In case the blood loss was = 200 mL, the subject was enrolled 60 days after blood donation.

12. A positive hepatitis screen including hepatitis B surface antigen and anti-HCV antibodies.

13. A positive test result for HIV antibody and / or syphilis.

14. The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study medication. Elimination half-life of the study drug was taken into consideration for inclusion of the subject in the study.

Note: If the subject had participated in a study in which blood loss was = 200 mL, the subject was dosed 60 days after the collection of last sample in the previous study.

15. An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study medicine and throughout the subject's participation in the study. In any such case selection of the subject will be at the discretion of the Principal Investigator/Medical Expert.

16. Uric acid parameters at the time of screening are not within clinically acceptable range.

17. History of gout and renal calculi.

18. Sitting blood pressure less than 100/60 mm Hg at the time of screening.

19. Haemoglobin less than 13 gm/dL at the time of screening.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Mycophenolate Mofetil
Mycophenolate Mofetil 500 mg tablets

Locations

Country Name City State
India Lambda Therapeutic Research Ltd Bodakdev Ahmedabad

Sponsors (1)

Lead Sponsor Collaborator
Dr. Reddy's Laboratories Limited

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bioequivalence on Cmax and AUC parameters 3 months Yes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03754920 - Prolonged Fasting With Meditation and Mild Physical Exercise N/A
Completed NCT05272332 - Gastric Ultrasound Prior to Extubation
Completed NCT04247464 - Short-term Fasting as an Enhancer of Chemotherapy: Pilot Clinical Study on Colorectal Carcinoma Patients N/A
Completed NCT01067001 - Minocycline HCl Extended Release Tablets 135 mg Oral Bioequivalence Study N/A
Completed NCT00757094 - Safety and Feasibility of Fasting While Receiving Chemotherapy N/A
Completed NCT01506713 - Bioequivalence Study of Clopidogrel Tablets 75 mg of Dr. Reddy's Under Fasting Conditions Phase 1
Completed NCT04514380 - Effect of Drinking Carbohydrate-containing Fluids on Gastric Residual Volume in Elderly Patients
Completed NCT05756868 - The Effect of Time-Restricted Feeding on Anthropometry, Biochemical Parameters, Diet Quality and Eating Behavior N/A
Completed NCT05134207 - The Effect of Oral Carbohydrate Solution on Anxiety and Comfort in Patients Undergoing Hip Arthroplasty N/A
Completed NCT05031598 - Long-term Fasting: Multi-system Adaptations in Humans N/A
Recruiting NCT04501393 - Recommended Clear Fluid Intake Volume at 2 Hours Prior to Esophagogastroduodenoscopy for Adult Patients N/A
Enrolling by invitation NCT04027478 - Can Fasting Decrease the Side Effects of Chemotherapy? N/A
Completed NCT05219136 - Improve the Comfort, Safety and Quality of Upper Endoscopy by a Modified Fasting Protocol N/A
Recruiting NCT04625608 - Effect of Premedicant Oral Paracetamol on Gastric Volume and pH Phase 4
Not yet recruiting NCT02562638 - Pre-Procedural Fasting in Cardiac Intervention N/A
Completed NCT01954836 - Short-Term Fasting During Chemotherapy in Patients With Gynecological Cancer- a Randomized Controlled Cross-over Trial N/A
Completed NCT01949987 - Does Oral Intake Decreases Postoperative Pain Score in Children N/A
Completed NCT01721187 - Satiety Effects on the Neural Valuation of Food N/A
Completed NCT01713647 - Bioequivalence Study of Amlodipine / Losartan/ Hydrochlorothiazide of PHARMALINE, Lebanon Under Fastion Conditions Phase 1
Completed NCT01831700 - Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fasting Conditions Phase 1