Clinical trials: Bioequivalence
Healthy
Topiramate 25 mg Capsule Mixed With Applesauce Under Fasting Conditions
The objective of this study was to compare the rate and extent of absorption or topiramate 25 mg capsules (test) versus Topamax® (reference) administered as the content of 2 x 25 mg capsules mixed with applesauce under fasting…
- Trial name
- NCT00905346
- Testing
- Topiramate 25 mg Capsules, Topamax® 25 mg Capsules, Applesauce
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
A Study in Healthy People to Compare How 2 Different Low Dose Formulations of BI 1015550 Are Taken up in the Body
The main objective of this trial is to establish the bioequivalence of the BI 1015550 Formulation C2 (Test, T) and the BI 1015550 Formulation C1 (Reference, R) following a single oral dose administration.
- Trial name
- NCT06408870
- Testing
- BI 1015550
- Where
- Germany
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Type 2 Diabetes Mellitus
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A)
To demonstrate bioequivalence of a 2.5 mg saxagliptin/500 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 500 mg metformin IR tablet co-administered to…
- Trial name
- NCT00899470
- Testing
- Co-administration of Saxagliptin and Metformin IR, Fasted, Saxagliptin/Metformin, Fasting, Co-administration of Saxagliptin and Metformin IR, Fed
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Therapeutic Equivalency
Fasted Bioavailability Study of Cilostazol Tablets, 100 mg
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under…
- Trial name
- NCT00684762
- Testing
- Cilostazol 100 mg Tablets, Cilostazol (Pletal®) 100 mg Tablets
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
Terbinafine HCl 250 mg Tablet Under Fasting Conditions
The purpose of this study is to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under fasted conditions in…
- Trial name
- NCT00833586
- Testing
- Terbinafine HCl 250mg tablets, Lamisil® 250 mg Tablets
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Cefprozil for Oral Suspension 250 mg/5 mL, Non-fasting
The objective of this study is to compare the relative bioavailability of cefprozil for oral suspension 250 mg/5 mL (TEVA Pharmaceuticals USA) with that of CEFZIL® for Oral Suspension 250 mg/5 mL (Bristol-Myers Squibb) in…
- Trial name
- NCT00835354
- Testing
- Cefprozil for oral suspension 250 mg/5 mL, CEFZIL® for Oral Suspension 250 mg/5mL
- Where
- 2 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Therapeutic Equivalency, Healthy
Fasted Bioavailability Study of Cilostazol Tablets, 50mg
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under…
- Trial name
- NCT00685802
- Testing
- Cilostazol 50 mg Tablets, Cilostazol (Pletal®) 50 mg Tablets
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants
The main purpose of this study is to evaluate amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via autoinjector compared to mirikizumab (reference) solution…
- Trial name
- NCT05515601
- Testing
- Mirikizumab
- Where
- 6 sites in United States
- Volunteers
- 396 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Volunteers
A Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 And Individual Reference Drugs In Healthy Volunteers
This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual reference drugs in healthy volunteers.
- Trial name
- NCT02014272
- Testing
- RIN 150, reference drugs
- Where
- Singapore
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Cilostazol 50 mg Tablets Under Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 50 mg Cilostazol Tablets manufactured by TEVA Pharmaceuticals Industries Ltd.
- Trial name
- NCT00839930
- Testing
- Cilostazol 50 mg Tablets, Pletal®
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Volunteers
Analysis of Crushed and Whole Tablet Genvoya
Step-wise, two sequential, single-dose, bioequivalence study in 12 healthy volunteers to determine whether crushed Genvoya tablet is bioequivalent to whole Genvoya tablet.
- Trial name
- NCT03717129
- Testing
- Genvoya Oral dose, Genvoya Crushed Dose
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Healthy Postmenopausal Females
Bioequivalence of Nomegestrol Acetate (NOMAC) and Estradiol (E2) in Commercial Versus Phase 3 Pivotal Clinical Batches of NOMAC-E2 Tablets (P06328)
For the contraceptive application a film-coated tablet has been developed which combines nomegestrol acetate (NOMAC) with estradiol (E2).
- Trial name
- NCT01345786
- Testing
- Commercial NOMAC-E2, Phase 3 NOMAC-E2 "Batch A", Phase 3 NOMAC-E2 "Batch B"
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Healthy
Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90 mcg Per Actuation in Healthy Volunteers Under Fasting Conditions
This study was designed to assess the bioequivalence between the test products (Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation) and the reference products (Proair HFA [Albuterol Sulfate] Inhalation Aerosol 90 mcg Per…
- Trial name
- NCT04803734
- Testing
- Albuterol Sulfate inhalation aerosol 108mcg per actuation, Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation
- Where
- Taiwan
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Intech Biopharm Ltd.
Healthy
Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg FDC Tablet and Telmisartan 80 mg Tab and Amlodipine 5 mg Tab Concomitant Use
To investigate the bioequivalence of telmisartan administrated in two different ways: both in telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan 80 mg tablet and amlodipine 5 mg tablets (R) in…
- Trial name
- NCT01344629
- Testing
- Telmisartan/Amlodipin FDC, Telmisartan, Amlodipin
- Where
- Japan
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Human Immunodeficiency Virus Type 1 (HIV-1)
Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat
The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir in a fixed-dose combination with cobicistat with that of atazanavir coadministered with cobicistat as single agents.
- Trial name
- Atazanavir (NCT01837719)
- Testing
- Atazanavir, Cobicistat, Atazanavir/Cobicistat FDC
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Prostatic Hyperplasia
SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fed Admin
It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the volunteers receive, in each period, the test formulation or the reference formulation, under…
- Trial name
- NCT01330303
- Testing
- Reference formulation, Test formulation
- Where
- Brazil
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Fever, Pain
Bioequivalence Study of Paracetamol With Oral Single Dose Administration in Healthy Adult Subjects Under Fasting Conditions
This study aims to evaluate the bioequivalence of new formulated orodispersible tablet (ODT) containing 500 milligram (mg) paracetamol in comparison to the European marketed Alvedon (paracetamol) 500 mg film-coated tablets and…
- Trial name
- NCT06855576
- Testing
- Paracetamol ODT, Alvedon film-coated tablet, Panadol film-coated Tablet
- Where
- Germany
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- HALEON
Bioequivalence
Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects Under Fed Conditions
This is a single center, Phase 1, randomized, open-label, single-dose, 2 treatment, 2-period,2-sequence, crossover study designed to compare the pharmacokinetics (PK) of sapropterin between the Test and Reference products in…
- Trial name
- NCT06987773
- Testing
- RLF-OD032 100 mg/mL oral suspension, Kuvan 100 MG Powder for Oral Solution
- Where
- Canada
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- APR Applied Pharma Research s.a.
Healthy
Bioequivalence of Two Different Capsule Types of Dabigatran
The objective of this Phase I trial is to demonstrate the bioequivalence of two capsules of dabigatran etexilate made from two different drug product batches.
- Trial name
- NCT01290757
- Testing
- Dabigatran etexilate
- Where
- Germany
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions
The object of this study is to compare the rate and extent of absorption of an investigational formulation of buprenorphine 8 mg sublingual tablets manufactured by Barr Laboratories, Inc.
- Trial name
- NCT01157169
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA