Clinical trials: To Determine Bioequivalence Under Fed Conditions
Bioequivalance
Clinical Study to Determine Bioequivalence Between Two Oral Medications of Sitagliptin/Metformin in Prolonged-release Tablets With 100 mg/1000 mg in Healthy Subjects, Fed Study.
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
- Trial name
- ACL25-IC005 (NCT07763964)
- Testing
- Janumet XR, Sitagliptin/Metformin FDC
- Where
- Mexico
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- ADIUM
Bioequivalence
Clinical Study to Determine Bioequivalence Between Two Oral Medications of Sitagliptin/Metformin in Prolonged-release Tablets With 50 mg/1000 mg in Healthy Subjects, Fed Study.
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
- Trial name
- ACL25-IC003 (NCT07763912)
- Testing
- Janumet XR, Sitagliptin/Metformin FDC
- Where
- Mexico
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- ADIUM
To Determine Bioequivalence Under Fed Conditions
Bioavailability Study of Tramadol/APAP Tablets Under Fed Conditions
To compare the relative bioavailability of Kali and Ortho-McNeil's products
- Trial name
- NCT00652821
- Testing
- Tramadol/ APAP, Ultracet
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Prostatic Hyperplasia
Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male.
Two tamsulosin HClformulations will be tested in fed state
- Trial name
- NCT02417844
- Testing
- tamsulosin (Astellas), Tamsulosin HCL
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
To Determine Bioequivalence Under Fed Conditions
Bioavailability Study of Leflunomide Tablets Under Fed Conditions
To compare the single-dose Bioavailability of Kali and Aventis
- Trial name
- NCT00653003
- Testing
- Leflunomide, ARAVA
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Healthy
A Study Of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta Under Fed Conditions
In Brazil, duloxetine is currently available as hard gelatinous capsule with delayed release microgranules for oral administration containing enteric-coated pellets of 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 30…
- Trial name
- NCT03794154
- Testing
- Cymbalta capsule, Duloxetine hydrochloride capsule
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer
To Determine the Bioequivalence Study Under Fed
Bioavailability Study of Metronidazole Capsules Under Fed Conditions
The purpose of this study is to compare the single-dose Bioavailability of Kali and G.D. Searle, Inc.
- Trial name
- NCT01380522
- Testing
- Metronidazole, Flagyl
- Where
- Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Bioequivalence Study in Healthy Subjects
Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 12.5 mg / 850 mg Tablets Under Fed Conditions.
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
- Trial name
- ACL24-PC019 (NCT07633028)
- Testing
- Empagliflozin/metformin 12.5/850 mg tablet (test), Synjardy 12.5/850 mg tablet (Reference)
- Where
- Mexico
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- ADIUM
To Determine Bioequivalence Under Fed Conditions
Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions
To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)
- Trial name
- NCT00652704
- Testing
- Doxycycline monohydrate, Monodox
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Healthy
Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions
To compare the single-dose bioavailability of Ondansetron ODT 8 mg and Zofran 8 mg
- Trial name
- NCT00653458
- Testing
- Ondansetron, Zofran
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Healthy
Bioequivalence Study of of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma, Egypt) and Janumet 50/1000 mg F.C.Tablets (Merck Sharp & Dohme, The Netherlands)
Comparative, Randomized, Single Dose, Two-way Crossover Bioequivalence Study to determine the bioequivalence of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma, Egypt) and Janumet 50/1000 mg F.C.Tablets (Merck…
- Trial name
- NCT05798715
- Testing
- Gleptomet 50/1000(Metformin HCl & Sitagliptin), Janumet 50/1000(Metformin HCl & Sitagliptin)
- Where
- Egypt
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Acne Vulgaris
A Study to Determine Bioequivalence of Isotretinoin in Healthy Male Subjects Under Fed Condition
This is an open-label, crossover, randomized, single dose, three treatments, three periods and six sequences, single dosage, balanced study to determine Bioequivalence of Isotretinoin.
- Trial name
- NCT02498288
- Testing
- Isotretinoin: Reference Medication 1, Isotretinoin: Reference Medication 2, Isotretinoin: Test Medication
- Where
- Mexico
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
To Determine Bioequivalence Under Fed Conditions
The Study Intends to Show Bioequivalence of the Test Product and the Reference Reference Product in a Crossover Design Study Healthy Volunteers. Additionally, the Safety Profile of Test Product Compared to Reference Product Will be Evaluated.
To evaluate and compare the relative bioavailability and therefore the bioequivalence of fixed dose combination of Metformin and Vildagliptin Tablets 1000/50 mg manufactured by Oman Pharmaceuticals Products Co.
- Trial name
- NCT05329857
- Testing
- Metformin and Vildagliptin 1000/50 mg
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- AET Laboratories Private Limited
Bioequivalence Study in Healthy Subjects
Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 12.5 mg / 1000 mg Tablets Under Fed Conditions.
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
- Trial name
- ACL24-PC020 (NCT07633041)
- Testing
- Synjardy 12.5/1000 mg tablet, Empagliflozin/metformin 12.5/1000 mg
- Where
- Mexico
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- ADIUM
To Determine Bioequivalence Under Fed Conditions
Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fed Conditions
The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen doxycycline monohydrate 100 mg.
- Trial name
- NCT01380496
- Testing
- doxycycline monohydrate
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
To Determine Bioequivalence Under Fed Conditions
A Comparative Bioavailability Study of Lisinopril Tablets, 40 mg - Effect of Food Study
The purpose of this study is to compare the bioavailability of Par Lisinopril 40 mg Tablets and IPR Pharmaceuticals, Inc. Zestril (R).
- Trial name
- NCT01380431
- Testing
- Lisinopril
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
To Determine Bioequivalence Under Fed Conditions
Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting and Fed Conditions
To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets
- Trial name
- NCT00652730
- Testing
- Buspirone HCl, Buspar
- Where
- Canada
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Bioequivalence
Clinical Study to Determine Bioequivalence of Oral Tamsulosin Products as 0.4 mg Prolonged-release Tablets in Male Subjects Under Fed Conditions
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x4, replicated, two treatments, four periods, two sequences controlled clinical study
- Trial name
- ACL25-PC007 (NCT07698288)
- Testing
- Tamsulosin 0.4 mg ER tablet
- Where
- Mexico
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- ADIUM
Gastrointestinal Diseases
Bioequivalence Study of Raperazole 20mg DR Tabs and PARIET® 20 mg DR Tabs Under Fed Conditions
This is an open-label, randomized, single dose, two-sequence, two-periods crossover study, separated by 7 days washout interval from the first Study Drug Administration.
- Trial name
- NCT02605395
- Testing
- IDIAZOLE 20mg DR tabs, PARIET 20 mg DR tabs
- Where
- Egypt
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioavailability Study of Torsemide Tablets Under Fed Conditions
To compare the single-dose bioavailability of Torsemide tablets with Demadex
- Trial name
- NCT00654043
- Testing
- Torsemide, Demadex
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.